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Challenges in Clinical Data Management: Findings from the Tufts CSDD Impact Report

Posted by Brook White on Fri, Feb 09, 2018 @ 12:24 PM
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Derek Lawrence, Senior Clinical Data ManagerDerek Lawrence, Senior Clinical Data Manager, has 9 years of data management and analysis experience in the health care/pharmaceutical industry.  Derek serves as Rho's Operational Service Leader in Clinical Data Management, an internal expert responsible for disseminating the application of new technology, best practices, and processes.

The most recent Impact Report from the Tufts Center for the Study of Drug Development presented the results of a study including nearly 260 sponsor and CRO companies into clinical data management practices and experience. A high-level summary of the findings included longer data management cycle times than those observed 10 years ago, delays in building clinical databases, a reported average of six applications to support each clinical study, and a majority of companies reporting technical challenges as it pertained to loading data into their primary electronic data capture (EDC) system.

These findings represent the challenges those of us in clinical data management are struggling with given the current state of the clinical research industry and technological changes. EDC systems are still the primary method of data capture in clinical research with 100% of sponsors and CROs reporting at least some usage. These systems are experiencing difficulties in dealing with the increases in data source diversity. More and more clinical data are being captured by new and novel applications (ePRO, wearable devices, etc.) and there is an increased capacity to work with imaging, genomic, and biomarker data. The increases in data changing EDC paradigmvolume and data velocity have resulted in a disconnect with the EDC paradigm. Data are either too large or are ill-formatted for import into the majority of EDC systems common to the industry. In addition, there are significant pre-study planning and technical support demands when it comes to loading data into these systems. With 77% of sponsors and CROs reporting similar barriers to effective loading, cleaning, and use of external data, the issue is one with which nearly everyone in clinical research is confronted.

EDC integrationRelated to the issues regarding EDC integration are delays in database build. While nearly half of the build delays were attributed to protocol changes, just over 30% resulted from user acceptance testing (UAT) and database design functionality. Delays attributed to database design functionality were associated with a LPLV-to-lock cycle time that was 39% longer than the overall average. While the Tufts study did not address this directly, it would be no great stretch of the imagination to assume that the difficulties related to EDC system integration are a significant contributor to the reported database functionality issues. With there already being delays associated with loading data, standard data cleaning activities that are built into the EDC system and need to be performed before database lock would most certainly be delayed as well.

Clinical data management is clearly experiencing pains adapting to a rapidly-shifting landscape in which a portion of our current practices no longer play together nicely with advances in data-mining.jpgtechnology and data source diversity. All of this begs the question “What can we do to change our processes in order to accommodate these advances?” At Rho, we are confronting these challenges with a variety of approaches, beginning with limiting the impulse to automatically import all data from external vendors into our EDC systems. Configuring and updating EDC systems requires no small amount of effort on the part of database builders, statistical programmers, and other functional areas. Potential negative impacts to existing clinical data are a possibility when these updates are made as part of a database migration. At the end of the day, importing data into an EDC system results in no automatic improvement to data quality and, in some cases, actually hinders our ability to rapidly and efficiently clean the data. In developing standard processes for transforming and cleaning data external to the EDC systems, we increase flexibility in adapting to shifts in incoming data structure or format and mitigate the risk of untoward impacts to the contents of the clinical database by decreasing the prevalence of system updates.

The primary motivation for loading data received from external vendors into the EDC system is to provide a standard method of performing data cleaning activities and cross-checks against the clinical data themselves. To support this, we are developing tools to aggregate that data from a variety of sources and assemble them for data cleaning purposes. Similar to the ways the banking industry uses machine learning to identify ‘normal’ and ‘abnormal’ spending patterns and make real-time decisions to allow or decline purchases, similar algorithms can identify univariate and multivariate clusters of anomalous data for manual review. These continually-learning algorithms will enable a focused review of potentially erroneous data without the development of the traditional EDC infrastructure. This will save time performing data reviews and also identify potential issues which we would normally miss had we relied on the existing EDC model. With the future state resulting in an ever-broadening landscape of data sources and formats, an approach rooted in system agnosticism and sound statistical methodology will ensure we are always able to provide high levels of data quality.

Revised Draft Guidance:  Formal Meetings with the FDA for Drug Products

Posted by Brook White on Wed, Jan 17, 2018 @ 10:52 AM
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Samantha Hoopes, PhD, RAC, Integrated Product Development AssociateSamantha Hoopes, PhD, RAC is an Integrated Product Development Associate at Rho involved in clinical operations management and regulatory submissions.  Samantha has over 10 years of scientific writing and editing experience and has served as lead author on clinical and regulatory documents for product development programs for a variety of therapeutic areas.

David Shoemaker, PhD, Senior Vice President R&DDavid Shoemaker, PhD, Senior Vice President R&D, has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs.  He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs and has moderated dozens of regulatory authority meetings.  

On 29 December 2017, the FDA released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.”  This draft guidance will replace the previous draft guidance posted in 2015 on this topic.  According to the draft guidance, from this point in time there will be 4 types of formal meetings with FDA staff:  

  • Type A
  • Type B
  • Type B (end of phase [EOP])
  • Type C

An overview of each type of meeting and the changes from the previous version of the draft guidance are highlighted below: 

A Type A meeting is necessary for a stalled product development program (at the behest of FDA) to proceed or to address an important safety issue.  Meetings of this type include dispute resolution meetings, meetings to discuss clinical holds, special protocol assessment resolution meetings, and post-action meetings requested within 3 months after an FDA regulatory action other than approval (i.e. complete response letter).  In the revised draft guidance, meetings requested within 30 days of FDA issuance of a refuse-to-file letter were also designated as Type A meetings.  For Type A meetings, FDA will aim to respond to a meeting request letter within 14 calendar days of receipt.  If a Type A meeting is granted, the meeting will be scheduled or a written responses only (WRO) communication will be sent within 30 calendar days from FDA receipt of the meeting request letter.  The requester must submit the Type A meeting package at the same time the meeting request letter is submitted and the FDA aims to provide preliminary responses no later than 2 calendar days prior to the scheduled meeting. 

Type B meetings include:  pre-investigational new drug application (pre-IND) meetings, pre-emergency use authorization meetings, pre-new drug application (pre-NDA)/pre-biologics license application (pre BLA) meetings, post-action meetings requested 3 or more months after an FDA regulatory action other than approval, meetings regarding risk evaluation and mitigation strategies of postmarketing requirements that occur outside the context of the review of a marketing application, and meetings held to discuss the overall development program for products granted breakthrough therapy designation status.  With the release of the revised draft guidance EOP1 and EOP2 (pre-phase 3) meetings no longer fall within this meeting category.  The FDA will aim to respond to requests for Type B meetings within 21 calendar days of receipt.  If the meeting is granted, the meeting will be scheduled or alternatively if the meeting is not granted WRO communication may be sent within 60 calendar days from FDA receipt of the meeting request.  The requester must submit the Type B meeting package no later than 30 days before the scheduled date of the meeting or WRO communication.  The FDA aims to provide preliminary responses no later than 2 calendar days prior to the scheduled meeting.

The revised draft guidance introduces a new category of meetings, Type B (EOP) meetings, which will include EOP1 meetings for certain products that will be considered for marketing approval under 21 CFR part 12, subpart E (Hearing Procedures), or 21 CFR part 314, subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses; Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics), and EOP2 meetings.  The FDA will aim to respond to requests for Type B (EOP) meetings within 14 calendar days of receipt.  If granted, a meeting will be scheduled or WRO communication will be sent within 70 calendar days of FDA receipt of the request.  The requester must submit the Type B (EOP) meeting package no later than 50 days before the scheduled date of the meeting or WRO response time.  As compared with Type B meetings, the FDA will aim to respond quicker to a Type B (EOP) meeting request; however, there will be a longer timeframe for scheduling the meeting and meeting packages will need to be sent in sooner due to the time required for FDA to review the greater volume of information contained in these meeting packages.  The FDA aims to provide preliminary responses no later than 5 calendars prior to the meeting and the requester should respond to the FDA within 3 calendar days after receiving the preliminary responses stating whether the meeting is still needed and providing an updated agenda including any questions that still require discussion.

A Type C meeting is any meeting other than a Type A, Type B, or Type B (EOP) meeting regarding the development and review of a product.  The revised draft guidance expanded this definition to specifically include meetings to facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use.  The FDA will aim to respond to meeting request letters for a Type C meeting within 21 calendar days of receipt.  If granted, a meeting will be scheduled or WRO communication will be sent within 75 calendar days of FDA receipt of the meeting request letter.  The revised draft guidance also specifies that meeting packages for Type C meetings that are requested as early consultations on the use of a new surrogate endpoint must be submitted at the time the meeting request is submitted while all other Type C meeting packages must now be submitted no later than 47 days before the scheduled date of the meeting or WRO response time.  According to the revised draft guidance, the FDA now aims to provide preliminary responses 5 calendar days prior to a scheduled Type C meeting and requires the requester to respond within 3 calendar days after receipt of FDA’s preliminary responses.

A summary of this information is provided in the table below (Appendix   Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products).

Meeting Type FDA Response to Request FDA Reciept of Meeting Package FDA Preliminary Responses to Requester (if applicable) Requester Response to FDA Preliminary Response (if applicable) FDA Scheduled Meeting Date (days from receipt of request) FDA Meeting Minutes to Requester (if applicable)
A 14 days With meeting request No later than 2 days before meeting -- Within 30 days 30 days after meeting
B 21 days No later than 30 days before meeting No later than 2 days before meeting -- Within 60 days 30 days after meeting
B (EOP)* 14 days No later than 50 days before meeting** No later than 5 days before meeting No later than 3 days after receipt of preliminary responses Within 70 days 30 days after meeting
C 21 days No later than 47 days before meeting*** No later than 5 days before meeting No later than 3 days after receipt of preliminary responses Within 75 days 30 days after meeting

Not applicable to written response only.
* EOP = end of phase
** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request, the requester’s meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the letter granting the meeting (see Table 1 in section VI.B., Meeting Granted).
*** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting the meeting (see Table 1 in section VI.B., Meeting Granted). Note that for Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the meeting request.

Consistent with the draft guidance from 2015, each meeting type consists of 3 different formats:  face-to-face, teleconference/videoconference, and written response only (WRO) and the FDA will issue finalized meeting minutes within 30 calendar days after any type of meeting.  The revised guidance still notes that requesters should attempt to combine product development issues into the fewest possible meetings.  Information pertaining to the content of a meeting request letter and meeting package is also outlined in the revised draft guidance.  According to the Federal Register, comments should be submitted on this revised draft guidance by 29 March 2018.   

An additional related resource includes the recently finalized guidance outlining the“Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” 

Webinar: Worried About Your Next FDA Meeting?

What Makes a SuperheRho: More Than a Coworker in a Cape

Posted by Karley St. Pierre on Tue, Nov 14, 2017 @ 09:33 AM
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“Who’s your favorite superhero?” No matter your age or gender, this question is commonly asked. It’s an ice-breaker of sorts—a response can tell a lot about someone’s personality and values. There are the typical, almost obvious answers—Batman, Superman, etc. Maybe you’d have a Marvel enthusiast throw in Iron Man for good measure. Or you could have someone aptly choose Wonder Woman as their favorite, what with this year’s blockbuster film making great strides in its genre. Regardless of who you choose the idea behind it is the same: who is someone you look up to, someone who can do anything incredibly. Superheroes are often thought of as being larger-than-life, having these unbelievable powers and instincts. They make great characters because their attributes are so incredible and uncommon. Yet, what we often forget is that we actually have superheroes around us every day, in real life—and at Rho. Between conducting clinical trials, giving keynote speeches at conferences, and participating in local philanthropy events, employees at Rho consistently go above and beyond. So, it comes as no surprise that we showcase our superhero staff when the time is right.

This past September, Rho celebrated being named to the Triangle Business Journal’s “Best Places to Work” list for 2017. The local publication holds nominations each year and honors the winners at a celebratory luncheon. Rho has been fortunate to receive this honor for 6 consecutive years, and each year Rho’s attendees choose their favorite hero-inspired shirt to wear. “When I was asked what character I wanted to be, at first I thought it was silly,” said Lane Bissett, a Business Development Associate with Rho. “Of course, I picked Wonder Woman like all the other ladies, but when I put on the shirt, it hit me.” Lane said that seeing herself alongside her Rho teammates, all wearing their chosen superhero tees, put an idea in her head. “We all are so different, but we all have these qualities that make us work great as a team. Representing Rho as this unified group of people felt really surreal.” Much like superhero squads in the movies, our team at Rho consists of many different personalities, strengths and talents. Whether it be a Clinical Research Associate or a Clinical Project Manager, every Rho employee has the opportunity to showcase their skill and knowledge while also learning from others. It’s a kind of collaboration that not only works but can be hard to find. 

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It’s this idea that makes Rho special—this unification of people and personalities towards one purpose and goal.  At Rho, that core purpose is to improve health, extend life, and enhance quality of life through corporate and research excellence. Each employee who represented Rho at the Triangle Business Journal Luncheon came from different sectors, holding different positions within the organization. “I was really proud when the announcers mentioned how Rho has won for the past 6 years,” said Joyce Lau, Research Associate. “It made us all feel kind of invincible,” she continued, “and it made me realize that there is a reason we can call ourselves superheroes here. We definitely had the most spirit, and it showed!” Throughout those 6 years, Rho has continued to see tremendous growth and opportunity, especially when it comes to adding more superheroes to the team. “When I came to Rho, the first thing I noticed was how great the people are,” Lane added. “Every day I feel lucky to work with the people I do, and it makes me excited to think of new hires joining and getting to see how amazing we are.” 

Shortly after Rho was honored at TBJ’s luncheon, we also celebrated our fiscal year end. At the celebration, employees were able to enjoy delicious food, interact with our CEOs and founders, and take home some pretty awesome Rho backpacks. “It felt like an early Christmas,”  said Joyce. “It just goes to show how much the people at Rho really care about you, really going above and beyond what you’d expect.” The year end celebration was a superhero convention it its own way—all our phenomenal heroes in one place.

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It’s not just the luncheons and gatherings that make us excited and proud to wear the title of “SuperheRho.” Just like the characters in comic books, every day brings a new challenge to face and every day we get to use our strengths to rise to the occasion. Recognition can be nice, but that’s not why superheroes do what they do. There’s an internal push for excellence and success, which Rho mirrors in our core values. So when we get asked who our favorite superhero is, chances are it’s someone here at Rho.

 

Highlights from TEDMED 2017

Posted by Brook White on Tue, Nov 07, 2017 @ 04:49 PM
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TEDMED TheatreLast week I had the opportunity to attend TEDMED 2017 in Palm Springs and want to share some highlights of the experience.  This certainly isn’t a comprehensive summary, but rather highlights of some of the themes that were most interesting to me.  

Understanding the Brain

In order to make significant progress on mental illness and neurological disorders, we need a better understanding of how the brain works.  Several speakers shared progress and innovation in understanding the brain.  Geneticist Steven McCarroll discussed drop-seq, an innovative method for understanding which cell types have which molecules.  Using this technology, his team has been looking at what genetic variations in individuals with schizophrenia may tell us about the underlying biology of the disease.  Chee Yeun Chang and Yumanity Therapeutics are using yeast to better understand how improper protein folding relates to brain disease.  Dan Sobek of Kernel discussed how electrical stimulation may be used to “tune” the brain both as a method for addressing brain diseases as well as increasing performance in normal brains.  Guo-Li Ming talked about creating organoids which are essentially mini-organs created using stem cells.  These organoids have been used to look at neural development and the Zika virus.  Jill Goldstein discussed sex differences in brain development and how that relates to disparities in the prevalence of some mental illnesses between sexes.  Collectively, it is amazing to see some of the progress that is being made on some very difficult diseases.

Delivering Healthcare on the Frontlines

Some of the most touching stories came from those on the frontlines of healthcare.  Dr. Farida shared her stories as the only OB-GYN left in Aleppo and what it meant to put herself and her family in danger to ensure women still had access to care.  Camilla Ventura is a Brazilian ophthalmologist who first connected ocular damage to Zika infection.  Dr. Soka Moses shared stories from the Ebola outbreak in Liberia and the challenges of delivering care with severe shortages of equipment, staff, and supplies.  Agnes Binagwaho returned to her home country of Rwanda following the genocide and told her story of rebuilding her country’s healthcare infrastructure.  Each of these stories was inspiring and a testament to humanity at its best. 

The Opioid Crisis

There were a number of talks as well as a discussion group focused on various aspects of the opioid crisis.  Perspectives were shared from law enforcement personnel, those working on harm reduction programs such as supervised injection sites, and treatment programs for addiction.  One of the most moving talks was given by Chera Kowalsky.  Chera is a librarian in the Kensington area of Philadelphia, an area that has been hit hard by the opioid crisis.  They’ve instituted an innovative program where librarians have been trained to deliver naloxone, and she shared her personal story of using naloxone to help save the life of one of the library’s visitors.  Despite the challenges posed by the crisis, it was uplifting to see the range of solutions being proposed as well as the commitment of those working on them.

The Hive

One of the most interesting aspects of TEDMED was the Hive. Each year, a selection of entrepreneurs and start-ups come to TEDMED to share their innovations in healthcare and medicine. These companies were available throughout the conference to talk with attendees. There was also a special session on day 2 where each entrepreneur had two minutes to share their vision with the audience.

Finally, perhaps the most valuable part of the experience was all of the people I had a chance to meet, each of whom is playing a unique role in the future of healthcare.

50 Must Have Travel Tips from Experienced CRAs

Posted by Brook White on Wed, Oct 25, 2017 @ 09:57 AM
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Recently, I sat down with Clinical Team Leads Caitlin Hirschman and Jamie Christensen who have a combined 25 years of monitoring experience to learn more about the travel tips they’ve acquired over the years.  Here’s what they had to share:

luggage and packing

General

1.  Expect the unexpected.  Things will go wrong, so you just have to be patient and stay calm when you are traveling.  Going in with the expectation that everything will go according to plan is a recipe for dissatisfaction.

2.  Get loyal with an airline and hotel chain so you can reap the benefits of their rewards systems (when it isn’t cost prohibitive).  You’ll appreciate the free upgrades and other goodies that you’ll collect over time. 

3.  Have cash. It comes in handy for tips and other small items.

4.  Invest in comfortable shoes.  Wear flats and bring sneakers.

Luggage & Packing

5.  Travel with a backpack and a carry-on.  Using a backpack rather than a purse or tote bag leaves your hands free which will make things much easier.  The backpack can also serve as the go to bag while you are on-site.

6. Invest in a good carry-on.  Consider one that is small enough to fit under the seat if you’ll be going on lots of overnight trips.  That way you won’t have to gate check your bag if they run out of room in the overhead compartments or if you are on a small regional flight that doesn’t accommodate roller boards.

7. Keep a ready-to-go toiletry kit that you don’t have to repack each time that contains carry-on size liquids.

8. Aveeno makes face wipes that work well as a non-liquid facial cleanser.

9. Pack light. A good rule is to pack two shirts for each pair of pants and re-wear the pants.
10. Pack clothes that don’t require ironing.

11. Bring some candy. It can make a good pick me up when you are feeling worn down.
12. Gum can come in handy too.

13. Don’t forget your chargers.

14. De-clutter your wallet so you are only carrying what you really need.

Air Travel

15. TSA pre-check is totally worth it. Not only does it provide the convenience of not needing to take off your shoes and take things out of your bags at airport security, but the shorter lines can save you a lot of time especially at larger airports. (Rho pays for TSA pre-check for frequent travelers).

16. Delta and Southwest are favorites for airlines. If you take Southwest, it’s worth it to pay for the early bird check-in so you get a better seat assignment. The cost will be offset by what you might have spent checking your bag.air travel

17. Consider joining an airline club. It can provide a really nice break during a long layover or if you get stuck because of a flight cancellation. (Rho pays for airline club membership for frequent travelers).

18. In general, aisle seats are preferred, but window seats may be better for a redeye.

19. Make sure to get a seat close to the front of the plane if you have a close connection, even if it means taking a middle seat. A middle seat is definitely preferable to a missed connection.

20. Don’t bring fish or beef jerky to eat on the plane. Your fellow passengers will appreciate it.

21. Avoid connecting flights through New York area airports. Atlanta is a good airport for transfers.

Ground Transportation & Parking

22. Consider using Uber to get from home to the airport depending on how long you will be gone and what time your flights are departing and arriving. It can be substantially cheaper than parking and you get dropped off close to the terminal at most airports.

23. If you do need to park, consider using an off-site parking service. You can earn points, they provide amenities like coffee and newspapers, and drop you off right by the terminal and your car. It can also feel safer than walking through a parking garage late at night.

24. Consider using Uber or other ride-sharing services in cities where parking can be a problem. This may also be a good plan if your visit is at an academic site. University parking is notoriously problematic.

25. If you have a good taxi driver, get their card so you can use them for the rest of the trip or future trips to the same city. It also allows you to call ahead for a ride.

Hotels

26. Download a noise machine app. It can help you sleep better in new places—particularly noisy ones.

27. Don’t sleep naked. You never know when there will be an unexpected hotel fire alarm.

28. When visiting a new site, ask them for hotel and restaurant recommendations.

29. Ask for a higher level hotel floor (never ground floor).

Health and Wellness

30. Bring an empty refillable water bottle and then fill it once you are on the other side of airport security. It’s easy to get dehydrated while you are traveling, and this is an easy, cheap, and environmentally-friendly solution.

31. Bring snacks. You never know when you are going to be stuck somewhere that it isn’t convenient to get food or where food options aren’t great. You can also choose healthier snack foods when you pack them yourself rather than purchasing them at the airport.

32. Make a plan to get in a workout wherever you go. It is easy to ignore your health when you are traveling frequently. Bring workout clothes and sneakers.eat healthy when you travvel

33. Check with your gym to find out if they have satellite locations in areas where you frequently travel.

34. Some hotels offer workout clothes and shoes that you can rent.

35. Keep your sneakers in your backpack, so you can take a walk and explore the city after work.

36. Keep hand sanitizer or baby wipes handy. Planes and airports are germy places.

37. Look under the mattress to check for bedbugs.

38. Beach Body Workouts is super cheap for a year membership. Just log onto the app and choose a workout like yoga or T25, which is a super quick great workout.

Safety

39. Make sure someone has your contact information and also knows your travel plans. Make sure to give the airline an emergency contact number. This is especially important for single folks who aren’t necessarily checking in with anyone regularly.

40. When the hotel asks you how many keys you want, always tell them two so that no one overhears that you are traveling alone.

41. Do a safety check of the hotel room before settling in. Check behind doors and in closets where someone could be hiding and make sure windows and sliding glass doors are locked.

42. If you are traveling to a new place, try to arrive when it is still light outside.

Food & Entertainment

43. Headphones for the plane are a must. You can use them to listen to music or movies, and to drown out the noise of the plane (or unruly passengers).

44. Before you leave on your next trip, download movies, books, or audiobooks to entertain yourself on the plane or when you have some free time back at your room.

45. Learn to enjoy travel by exploring each place you go. There are a number of “Best of” apps that tell you the best sandwich, beer, dessert, etc. in each state. It can be fun to see how many you can collect.

46. Some restaurant and hotel chains have happy hours which can save you some money if you are traveling on a per diem reimbursement plan. In some cases, hotel happy hours provide free food that make for a decent light dinner.

47. Bring a bathing suit. If you have free time you can get some exercise in the pool or some relaxation time beside it.

48. Go see landmarks in new cities you visit—the Seattle Space Needle, Millennium Park in Chicago, Duck Tours in Boston, Riverwalk in San Antonio.

49. Baseball games are a great way to take in some local flavor at a reasonable cost.

50. Check out some local restaurants.

What are your best travel tips?  Share in the comments below!

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Breaking Bad (Meetings)

Posted by Brook White on Tue, Sep 19, 2017 @ 10:57 AM
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Ryan2.jpgRyan Bailey, MA is a Senior Clinical Researcher at Rho.  He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) project. 

In Hamlet, Shakespeare posed the most famous existential question in English theater -- “To be, or not to be?”

If the Bard were to write a play for the 21st century office, he might ask a different, but no less poignant, question – “To meet, or not to meet?”

Few topics seem to elicit more workplace dread than the meeting. We tend to view meetings as disruptions, time sinks, resource devourers, and productivity killers. When someone says they “spent all day in meetings,” we don’t assume they got a lot accomplished; we assume their day was a bust.

Given the angst that seems to accompany meetings, we’ve been trying to rethink how we approach them at Rho. To help, we’ve been drawing inspiration from Deep Work, by Dr. Cal Newport. The premise of Deep Work is that our technology-driven culture is inadvertently inhibiting our ability to do focused, cognitively-demanding, high-impact work. Instead, our work is increasingly defined by fragmentation, interruption, and distraction, as we let our inbox and meeting schedule dictate the work we do.

Dr. Newport’s work struck a chord with us. Yet, we cannot escape the fact that our work requires the type of synchronous collaboration and context-rich communication that only meetings can provide. Here again we have an existential question: If meetings are so fundamentally important to our work, why are they so painful and disruptive?
Our honest take: We’re bad at them and we overuse them.

Most of us stink at meetings. We stink because we’ve fallen into the trap of thinking that meetings are easy. We show up and talk about the same stuff every week for an hour. What’s hard about that? In reality, effective meetings require thoughtful planning and careful execution from leaders, as well as mindful preparation and active participation from attendees.boring_meeting.jpg

Calendar software has exacerbated our problem by making it too convenient to schedule meetings. Rather than stopping to think if a meeting is needed, or if our objectives could be accomplished in a more effective way, we schedule the meeting because it’s easy. The classic example of this is the status update meeting. If the whole point of your meeting is to go around the room and give status updates to your teammates – something that could be done via email or chat with far less disruption – you have created a zombie meeting, an undead horror sucking the productivity out of your colleagues!

Many of us also have the bad habit of scheduling meetings as a form of procrastination. Instead of trying to solve a problem now, we punt it to our next meeting. While there’s nothing wrong with deferring a difficult issue until you can discuss it as a team, swamping the agenda with our postponed to-do lists is certain to “zombify” a meeting. The especially painful result of this tactic is that instead of taking a few minutes to solve the problem on our own, we multiply the resource burden. A 15-minute task dragged into an 8-person meeting effectively becomes a 2-hour task.

So, what’s to be done to salvage meetings and make them productive and engaging? One approach that we advocate among both meeting leaders and attendees is to follow the FSB mantra to meetings: Fewer. Shorter. Better. Here’s some advice we recently provided to our employees about FSB meetings:

Fewer – The challenge here is to not merely cut meetings, but to cut intelligently.  

  • Leaders: Think critically before you schedule a meeting.  Do you really need it?  Can you accomplish your objectives in a better way? For recurring meetings, take a look a day ahead of time and decide if you can cancel it. 
  • Attendees: Think critically before you attend a meeting. Do you need to be there? Read the agenda. Do you know which topics pertain to you? What will you contribute or learn? If you are unsure, contact the meeting coordinator and ask.
One alternative to cancelling a meeting is to rethink your meeting format. Could updates be sent from email and the meeting cancelled outright? Would a brief stand-up meeting suffice instead of an hour-long time drain? What about a brief teleconference from your desk? wood-table-meeting.jpg


Shorter – Meetings are notorious for taking up as much time as you allot for them. When you have back-to-back meetings, this leads to meeting room overlap, frustration, and the domino effect of late-starting meetings. Instead, try the 25/50 rule: reduce 30-minute meetings to 25 minutes and hour-long sessions to 50 minutes. This provides buffer to conclude your meeting and head to your next engagement on time.

Better – The single most important factor for better meetings is being prepared. Not knowing why you are at a meeting, what will be discussed, and what you hope to accomplish is certain to create a poor meeting.

  • Leaders: Serve your attendees well by following the basics of good meetings: 
    • Have a goal
    • Think critically about who should attend
    • Provide context ahead of time
    • Stay on time and on task
    • Endeavor to engage everyone in the room

If you are struggling with these steps, try setting aside time to prepare for your meetings.  You may also find that you are leading too many meetings.  In which case, you should share the load (this is a great way to help train up more junior team members!)

  • Attendees: Don’t settle for bad meetings.  Speak up and provide helpful, candid, and constructive feedback.  But also, when you’re in a meeting, be a helpful attendee:
    • Request that items be added to the agenda ahead of time
    • Come prepared to address the sections of the agenda you’re responsible for
    • Avoid the temptation to commandeer or disrupt the meeting

Meetings don’t have to be a source of frustration or disruption.  To the contrary, meetings can be some of the most productive times of our day – where we solve problems, brainstorm, and find creative inspiration – provided we execute them properly.  

When is the last time you did a self-evaluation of your meetings?  If it’s been a while (or never), consider taking 15 minutes this week to think critically and creatively about your current meetings.  How can they be pared back, truncated, and refined to make them more effective and productive?  When done right, following the FSB mantra can do a lot to return some much-needed productive time to your schedule.

Watch: Meet Our Experts

12 Resume Tips That Can Help You Get a Clinical Research Job

Posted by Brook White on Wed, Sep 13, 2017 @ 11:36 AM
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resume tips for clinical research jobsI’ve been working at Rho for 10 years and at CROs for more than 15 years, and in that time, I’ve reviewed a lot of resumes for job seekers in many different positions. Here are some resume and CV tips to help you stand out with the recruiters, hiring managers, and interview teams that make the difference between getting an interview or a rejection letter for the clinical research job you really want.

Note: The tips I’m sharing here are for job seekers in the US. International standards can differ.

Keywords Matter

In most cases, the first look at your resume won’t be a thorough one. During that first pass, a recruiter is probably looking for a handful of keywords that they associate with the position. What terms are you using to search for jobs? Those same terms should show up prominently on your resume.

Does that mean you can’t get a job if you haven’t held that job before? No. You just need to make sure that it is clear how your experience is applicable. For example, if you are seeking a job as a CRA but haven’t had CRA as your title, you can still make sure that words like monitoring and site visit show up in the accomplishments and descriptions of your roles. For competitive positions, most candidates are screened out during this step. Make sure you’re not one of them.

Proofread, Proofread, Proofread

I’m always surprised by the number of resumes I see that have basic spelling, grammar and formatting errors. Generally, I wouldn’t consider hiring someone with these sorts of errors. This may sound picky, but clinical research requires close attention to detail for nearly every position at every level.

You should carefully proofread your resume. Then, ask someone with strong writing and editing skills to do the same. Don’t have access to someone that’s up to the job? Check out Grammarly. It is a free online tool that will eliminate most of these errors. Make sure you list the correct company and job title for which you are applyi

best candidate for a clinical research job

ng. Listing either one incorrectly shows a lack of attention to detail and tells the recruiter you aren’t committed to their company.

Tailor Your Resume to the Position

Start by carefully reading the posted job description.  What specific skills and experience does the job require?  Make sure you highlight these skills on your resume and that it is obvious how your experience aligns with the required experience for the job.  What are the primary job duties and responsibilities?  Call-out how you have accomplished similar tasks in your previous work.  Finally, review the company’s website to see what values they highlight.  Quality? Teamwork? Fast-paced environment?  Think about how you can demonstrate the attributes they are looking for in the materials you are submitting.  This may seem daunting, but submitting 10 tailored resumes will produce better results than submitting 100 generic ones.  List your applicable skills at the beginning of your resume, not the end.  You want to capture the attention of the resume reviewer quickly.  

Demonstrate Knowledge of the Industry

Whether you are a clinical research veteran with 20 years of experience or are seeking an entry level position, your resume should reflect awareness of what is happening in the industry. If you are new to the industry or returning to the industry, there are a number of great free news sources that can help you with this. A few of my favorites are FierceCRO and FierceBiotech, Clinical Leader, and Applied Clinical Trials.

Consider how to work in key trends. Searching for a clinical operations role? Highlight your experience with risk-based monitoring. Looking for a job in clinical project management? Mention your experience working with patient advocacy groups to improve patient recruitment. Obviously, the depth of knowledge and awareness expected will differ based on your role and experience level, but these are the kinds of things that can be differentiators in a competitive field. One thing to note – make sure you can speak to every item on your resume if asked about your experience – no fabrications. If you can’t articulate that particular skill or ability during an interview, don’t list it on your resume or CV.

Formatting

This is not a creative or design-focused industry.  Your resume does not need to be a work of art, but basic proper formatting is expected.  Use an easy to read font and font size with a light background color and a dark font color.  Have reasonable margins.  Use bullets.  Limit your resume to 2-3 pages maximum.  Focus on making it easy to read and easy to find desired information.  There are plenty of good free templates out there, so consider using one of those if you aren’t sure what good formatting looks like.

Cover Letter—Yes or No?

happy_business_colleauges.jpgWhether or not to include a cover letter depends both on your resume and the position for which you are applying. In some cases, it will be obvious how your skills and experience are transferable to the posted position. For example, you currently are a clinical data manager with experience in EDC system x and skills y and z applying for a job as a clinical data manager with experience in EDC system x and skills y and z. In this case, a cover letter isn’t necessary, although it would provide an opportunity for you to explain why you are interested in that company or that position.

In some cases, there isn’t a straight line between your work experience and the position you’re applying for. Or, maybe there is something on your resume that you would like to explain like a gap in your work history. Or, maybe the position is in another location and you want to voice your willingness to relocate. A cover letter can help you with any of these situations. If you do include a cover letter, make sure it is concise, well-written, and offers something more than what would be obvious from reading your resume. And don’t forget to ask a friend to proofread your cover letter! A great resume will be overlooked by a poorly written and grammatically incorrect cover letter.

Accomplishments Not Duties

For each position, you should include a brief summary of the responsibilities followed by a couple of core accomplishments.  It should not be a bulleted list of the twenty duties in the job description.  Finally, accomplishments should be specific and should include metrics where possible.  For example, a clinical project manager might list an accomplishment like “For a global phase 3 study, completed enrollment 6 weeks early and delivered topline results 3 days after database lock.”  This resume will get a lot further than one with a list that says managed global phase 3 studies, oversaw data management and statistical deliverables, and managed timelines.

Technical Skills

Recruiters and hiring managers are often looking for specific technology skills and even experience with specific software systems.  Ideally, these would be listed in the job posting, but that isn’t always the case.  Include both industry system types like CTMS, EDC, IRT, and statistical programming languages as well as specific system names like Medidata Rave and SAS.  Also include industry agnostic technologies that may be applicable to your role like MS Project, HTML, or Java.  If you have experience in clinical research, you should also list the therapeutic areas where you have experience. Also make sure to list any certifications like the Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or Certified Clinical Research Associate (CCRA).

How Long Should My Resume Be?

The answer to how long your resume should be depends on how much work experience you have and the type of job you are seeking.  For recent graduates and early career candidates, about a page is a good rule of thumb.  For experienced candidates in most roles, 2-3 pages is an appropriate length.  For scientific roles where publications are expected to be included, CV length is highly variable and should be driven by career length, number of professional positions, and number of publications; however, you still want your biggest selling points on the first couple of pages.

Things You Don’t Need to Include on Your Resume

There are also a number of things you shouldn’t include on your resume:

  • Personal or demographic information like age, race, gender, religious preference, social security number, or marital status.
  • Photos.
  • Salary history or salary requirements.
  • “References available on request”—this is assumed, takes up space, and can make your resume seem dated.
  • Objective—I’ve never seen an objective that has made a difference in my decision for the positive.  However, an objective that isn’t well written or doesn’t align with what I’m looking for has caused me to rule candidates out.

Advice for Recent Graduates

Many recent college graduates struggle with what to include on their resumes besides their education if they don’t have professional work experience.  That is totally fine—when we are hiring entry level candidates we don’t expect them to have professional work experience.  Some beneficial things you can include are:

  • Volunteer experience
  • Non-professional work experience from restaurant jobs to dog walking to mowing lawns in the summer
  • Study abroad programs
  • Internships
  • Extracurricular activities, especially leadership positions
  • Class projects that are relevant to the position

Each of these provides valuable information about you.

Interested in working at Rho? Learn more about working at Rho!

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10-Step Commercial Clinical Protocol Authoring Guide

Posted by Brook White on Thu, Aug 31, 2017 @ 01:57 PM
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Lauren Neighbours, PhD, RACLauren Neighbours, PhD, RAC, is a Research Scientist at Rho. She leads cross-functional project teams for clinical operations and regulatory submission programs. Lauren partners with early-, mid-, and late-stage companies to develop and refine strategic development plans, design and execute clinical studies, lead regulatory submissions, and provide support for regulatory authority meetings and other consulting needs. She has over ten years of scientific writing and editing experience and has served as a lead author on clinical and regulatory documents for product development programs across a range of therapeutic areas.

Devin Rosenthal, PhDDevin Rosenthal, PhD, RAC, works with companies at all stages of development to help them shape their product development programs. He has experience across the full drug development spectrum through his roles in small biotech, big pharma, and at Rho, with particular focus on oncology, CNS, gastrointestinal, and respiratory indications. In addition to pharmaceutical development, Devin is also involved in strategic alliance and business development activities at Rho.

Genna Kingon, PhDGenna Kingon, PhD, RAC, is a Research Scientist at Rho involved in regulatory strategy and submission management from pre-IND to post-approval.  She also serves as a lead regulatory author on multiple programs for submissions to FDA and to various international regulatory authorities.  In particular, Genna focuses on rare disease programs and expedited approval pathways. 

begin with the end in mindA protocol is the most important document in a clinical study as it is the foundation for subsequent operational, regulatory, and marketing objectives for the development program. 

 Developing a protocol is an extensive undertaking that requires a cross-functional team and consideration of the position and role of the study in the full product development program.  Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success.  The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol. 

Pre-Authoring

1.    Begin with the end in mind

our program team should first prepare an Integrated Product Development Plan (IPDP). This plan, which is largely based upon the desired final Target Product Profile (TPP) and product labeling, maps out all activities through marketing application submission and clearly outlines the purpose, position, and necessity of each study in the product development program. Without these documents, you run the risk of completing a study that fails to advance your product’s development or is markedly less valuable to development than it otherwise could be.

Among other things, the IPDP should contain the clinically meaningful endpoint(s) for your studies that will be acceptable to regulators and support the desired marketing claims for the product. Additionally, the IPDP should include an assessment of the actual and potential competitive products likely to be on the market at or near the time of product launch. This information will be essential for optimal study design and conduct, and will therefore improve the chances of ultimate product success. Cross-functional input and buy-in from all key internal and external stakeholders for each study, as well as on the full development plan, is a necessity.

2.    Design the study

clinical study designBefore you start thinking about the protocol study procedures and visit schedule, you need to understand your overall goals for the study, and how the data that are collected will not only support your product development strategy but ultimately move your program forward. For studies in the early phase of development, consider first outlining the study objectives, as well as the endpoints that specifically address those objectives in a measurable and meaningful way. The design of the study should then flow from those objectives and endpoints, making sure the technical and logistical aspects of the protocol maintain a focus on the end goals.

For all studies, consider developing the statistical analysis plan (SAP) before drafting the protocol. During SAP development, the study objectives and endpoints are comprehensively considered and designed, along with the specific analytical methods needed to optimally interpret the data. Choose a sample size that has sufficient statistical power to reliably detect outcomes and differences of interest and that meaningfully contributes to accumulation of an adequate safety database for your product, but is also as practical as possible to enable successful study completion. Then, explore study design options with the protocol objective(s), SAP, and the TPP in mind.

In designing your study, take the following into account:

  1. Map out how key study measures will be assessed, with what frequency, and in what kind of study population.  Properly defining the study population is essential, particularly to ensure that the inclusion and exclusion criteria appropriately select for the eventual target population, as well as for optimal assessment of safety and efficacy in that population. 
  2. Be sure that existing animal toxicology data are adequate to support any proposed duration of dosing, dose levels, and specific subject eligibility criteria.
  3. Be mindful of manufacturing capacity and schedules for study drug to ensure that your study is feasible given the cost of goods and timelines for manufacturing.  You may have to adjust the dosing duration, dosage, number of dose levels, or your study timeline to accommodate manufacturing limitations.  Even after your drug is manufactured, you may want or need to develop specialized packaging such as blister packaging or cold-chain logistics to help ensure study success.
  4. Remember that the more complex the study design (e.g., number of arms, number of objectives and endpoints, number or complexity of assessments), the greater the chances for errors, omissions, data quality issues, and unexpected complications during study execution; and, therefore, the greater the chance for study failure.  Study design should be laser focused on what is required to produce only the information necessary for product labeling and/or to progress the compound to the next stage of development.  For this reason, it is also important to avoid the common temptation of adding “nice-to-have” but inessential study components during the course of protocol development. 

3.  Define technical details

Establish or obtain an International Conference on Harmonisation (ICH)-compliant protocol template and develop and maintain a style guide and/or list of writing conventions to ensure consistency and clarity within and between study documents.  Establish the appropriate reviewing processes, and identify cross-functional reviewers (editorial, regulatory, clinical, statistical, data management, medical, product safety, senior management, etc.).  Record all key decisions and their rationale throughout the development and writing process.  Failure to do so may result in frequently having to revisit issues, causing unnecessary delays and changes in the protocol or development plan.

4.  Draft the synopsis

Generate the study schedule of events, and draft the synopsis.  The synopsis should be no more than 10 pages total.  Obtain feedback from cross functional subject matter experts, senior leadership from the sponsor/contract research organization (CRO), and potential clinical investigators and study site staff.  Revise and finalize the synopsis:  this is the foundation for the clinical study protocol.  

Protocol

5.  Define operational details

Consider essential operational logistics such as laboratory test results required to enroll and/or randomize subjects (e.g., will this require local labs as opposed to a central lab?), total blood volume drawn, equipment and space necessary for subject evaluation, availability of specialist(s) for nonstandard assessments, storage and shipping requirements for clinical specimens and investigational product, and scheduling limitations/conflicts for study visits.  Consult both sponsor and CRO operations staff and study sites as necessary to determine the feasibility of the proposed operational plan.  

6.  Minimize the potential for amendments

simplify the protocol where possibleConsider what qualifies for inclusion in the protocol; detailed information that is not directly relevant to study conduct is usually better suited for operations manuals, which can be more easily updated throughout the study.  Avoid redundancy within the protocol; state everything once.  Use the synopsis as a tool to establish the foundation of the protocol.  At the completion of protocol development, the synopsis should be reviewed to ensure it accurately reflects the content of the final protocol (if it is intended to be appended to the protocol or used separately as an internal reference tool).  Continuously revising the synopsis while the protocol is being written is unnecessary and discouraged as this invariably leads to errors in one document or the other, as well as in the resulting study.  Whether or not a synopsis is included in the final protocol itself is often a matter of sponsor preference. 

7.  Draft the protocol

Prepare the protocol draft by expanding on the detail in the synopsis regarding the investigational plan, study schedule, analysis plan, safety monitoring, and the other outlined provisions.  Much of the protocol should be derived from template language, which generally does not change from protocol to protocol, but rather, only changes periodically following revised regulatory requirements or other administrative preferences.  Obtain additional review from cross-functional subject matter experts (which may include patient advocacy groups, as applicable), the sponsor and/or CRO personnel, and select study investigators.

Download: Protocol Template

Concurrent and/or Post-Protocol

8.  Draft the informed consent form (ICF)

Using an established and compliant informed consent form (ICF) template, draft the ICF with finalized protocol information at the appropriate reading level for the intended study subjects, which is rarely greater than about an eighth-grade level.  Obtain cross-functional subject matter expert and sponsor/CRO/site feedback.  Revise and finalize the form, which may require site- and institutional review board (IRB)-specific information or even site/IRB specific template language.  While the consent must include all required regulatory elements, strive to make the consent form as short as possible and without repetition.  A consent form that is overly complicated or too long to be easily read and understood fails in its purpose.

9.  Design case report forms (CRFs)

case report forms (CRFs)Capture data efficiently (fewer queries) with appropriate and reasonable CRF pages.  Be considerate of open-ended text boxes versus check boxes:  while an open-ended text box is preferable for describing unexpected, non-categorical events, check boxes are better for categorical items (e.g., ethnicity) to reduce the need for queries and to facilitate downstream data analysis.  The CRF should undergo interdisciplinary review by representatives from key functional areas (i.e., data management, biostatistics, programming, clinical operations, regulatory, safety, medical affairs) prior to finalization. 

10.  Design and compile operations manuals

The clinical sites will reference operations manuals for additional study information that is not specified in detail in the protocol (e.g., pharmacokinetic sampling procedures, shipping information, tissue collection procedures, investigational product preparation/dispensation, study contact information, etc.).  Use the manuals as an easily accessible reference for site study staff and a repository for information that has the potential to change during the study (e.g., shipping addresses if personnel/vendors are likely to change).

Download: Protocol Template

 

Could Your Drug Development Program Benefit from an NDA/BLA/PMA Gap Analysis?

Posted by Brook White on Wed, Aug 23, 2017 @ 09:37 AM
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David Shoemaker, PhD--Senior Vice President R&DDavid Shoemaker, PhD, Senior Vice President R&D, has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs.  He has managed or contributed to more than two dozen NDAs, BLAs, and MAAs and has moderated dozens of regulatory authority meetings.  

Jack Modell, MD--Vice President and Senior Medical OfficerJack Modell, MD, Vice President and Senior Medical Officer, is a board-certified psychiatrist with 30 years of experience in clinical research, teaching, and patient care including 10 years of experience in clinical drug development (phases 2 through 4) and successful NDA filings. Dr. Modell is a key opinion leader nationally known for leading the first successful development of preventative pharmacotherapy for the depressive episodes of seasonal affective disorder.

scott-burian.jpgScott Burian, PhD, Senior Research Scientist, has contributed to the development of a diverse range of small molecule, biologic, and nanoparticle-based products.  He has participated in numerous FDA interactions, including pre-IND meetings, Type A meetings, and Advisory Committee meetings. He is fully-versed in eCTD format and has authored a variety of CMC submissions, including numerous pre-IND meeting packages, INDs, NDAs, and IMPDs.

bridging the gap between clinical data and NDA submissionHere at Rho, we’ve helped many companies with their marketing application submissions. In fact, in the past six years, we’ve been a key service provider on 14 submissions, provided biostatistics support for 30 submissions, and prepared over 20 Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) SAPs. Over the course of working on these submissions, one common hurdle we see is that Sponsor companies often enter this stage without a strong understanding of what data they have and how that maps to a viable approval pathway.

Whether you plan to file a new drug application (NDA), a biologics license application (BLA), or a premarket approval application (PMA) with the FDA or a marketing authorization application (MAA) with the European Medicines Agency, you’ll need an in depth understanding of how the data you have from your clinical studies, nonclinical studies, and Chemistry, Manufacturing and Controls (CMC) / Quality development map to the requirements of the application. These requirements can be specific to the therapeutic area or regulatory authority, and are continually changing as science advances.

Discovering you don’t have all the data you need as you begin preparing your marketing application can lead to costly time delays. What can be done? We recommend undertaking a gap analysis following proof-of-concept in Phase II. This timing allows you to design your adequate and well-controlled studies to attain all necessary clinical data. Performing the gap analysis at this stage of development will also provide enough time to conduct additional nonclinical studies or CMC development that may be needed to support the application.
You need a cross-functional team of medical, regulatory, clinical, statistical, CMC, and toxicology experts with experience getting a product to market, ideally in the therapeutic area of interest. Many small to mid-size companies don’t have all of this expertise in-house, so the team will need to bring in outside support in the form of consultants or a contract research organization (CRO) that has this expertise.

A gap analysis starts with a detailed look at the existing data and regulatory communications. What is the format of the data? Anything you plan to submit will need to be in CDISC format, so if you need data from legacy studies, the data must be converted to CDISC format if the study was initiated after December 2016. Next, look at the label claims you plan to make. Do you have (or have a plan to collect) all the data needed to support those claims? This can be difficult to determine.

mapping clinical dataOnce you’ve determined the data you have and the data you’ll need, create a map that clearly identifies the deficiencies in your database. You may find that there are very few gaps and the data you’ve collected and will collect in your pivotal studies will adequately support your marketing application. You may also realize that you don’t need all of the data from your legacy studies, which can save you some time and money in CDISC conversion costs. Conversely, you may identify significant gaps in your database that require additional studies. That is still a good outcome because by performing the gap analysis you have clearly identified what needs to be completed and you will have sufficient time to gather the additional data. This could mean just completing your Phase 3 studies, or performing additional clinical (e.g. food effect studies) or nonclinical studies, or CMC development work, thus ensuring that upon completion of the Phase III studies, you will have a clear path to your marketing application submission.

So, is the additional time and expense of conducting a gap analysis worth it? Rho believes that the answer is most definitely, yes. However, we typically recommend waiting until proof-of concept has been demonstrated to conduct this analysis. At that point, you should have convinced yourself that you have a viable product and have a general idea of its characteristics and potential value to patients. An experienced team of medical, nonclinical, CMC, regulatory, and statistical experts can conduct a gap analysis relatively quickly and for a relatively limited cost. When compared to a significant delay between the end of Phase 3 and submission or an unsuccessful marketing application submission, it is almost certainly worth it.

Download: Marketing Application Planning Tool

How much does a clinical trial cost? Understanding the 8 major factors driving CRO bids

Posted by Brook White on Tue, Aug 15, 2017 @ 09:32 AM
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how much a clinical trial costsThis is a question we frequently get in some form from Sponsors in early phases of development that are trying to figure out what it will cost to hire a CRO to conduct their clinical trials and associated regulatory activities. While the high degree in variability between trials would make it difficult to provide a single answer, we can explain what factors can drive costs up or down.

If you already have well defined information about your clinical trial, use this RFP specifications tool to request a more accurate and detailed estimate from Rho or another CRO.

Clinical Trial Cost Drivers

While there are many variables that can impact a clinical trial budget, these are some of the most common ones:

  1. Therapeutic Area: What therapeutic area or indication is the focus of the program?  Some will be more expensive than others.  For example, oncology studies are frequently highly complex and, in general, will be more costly than say an ophthalmology study with the same number of sites and subjects.
  2. Study Duration: How long will a study last?  Short studies like a seasonal allergy study where enrollment happens quickly and the treatment period is relatively short would typically be a less expensive study than one that may require many months of treatment and follow-up.
  3. Number of Patients: How many patients are needed?  The more patients needed, the higher the costs will be.  Later phase studies where an accurate assessment of efficacy is needed tend to be more expensive than earlier phase studies where establishing safety is the primary objective.
  4. Number and Location of Sites: How many sites do you need and where will they be located?  The more sites you need, the higher the cost will be.  Geography is also important.  In general, costs will increase for every additional country you add.  Also keep in mind that conducting studies in some countries will be more expensive than in others.
  5. Number of Labs and Procedures: The number and complexity of labs and procedures will impact the costs.  This includes direct costs from the CRO to monitor and manage the data as well as increased pass through costs from sites and central labs.
  6. Patient Population: Are you studying healthy or sick patient populations?  What is the prevalence of the indication?  This will impact your costs both in terms of safety considerations and speed of enrollment.  How much competition is there?  If you are working with a small patient population and multiple competing studies, this will likely drive up costs for patient recruitment as well as potentially increasing the enrollment duration.
  7. Clinical Monitoring Plan: How frequently do you anticipate needing monitoring visits?  The total number of monitoring visits is a key cost driver and will be determined by the frequency of visits desired as well as the duration of enrollment and treatment.
  8. Safety Profile: What are the safety concerns with the treatment and patient population?  The number and seriousness of adverse effects (AEs/SAEs) will impact costs, as will the need for a data safety monitoring board (DSMB) and any interim analyses needed to support it.

Looking for an answer tailored to your clinical study? Please contact us for cost estimates tailored to your program.  We're also happy to set up an expert consultation if you need assistance figuring out how these cost drivers apply to your program.

Kara Roberts, Director Proposals and Contracts, contributed to this post.

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