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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.

5 Tips for Creating an RFP

5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services

Posted by Brook White on Tue, Feb 14, 2017 @ 11:13 AM
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RFPs tips that allow apples to apples comparisons of clinical trial servicesIf you’re looking for a contract research organization (CRO) to provide clinical trial services, chances are you’ll need to create a request for proposal (RFP). In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

Here are five tips for creating RFPs that will help you compare “apples to apples” and help the CROs better understand your needs, values, and selection criteria for your clinical trial services:

  1. Provide background information on your compound and program.  Information about other clinical studies completed or in progress, outcomes from preclinical work, regulatory strategy and even funding and marketing plans can provide context that will help a CRO understand your needs and give you a proposal that best addresses all of your concerns.
  2. Provide a protocol or protocol synopsis.  Details about the study, such as number of clinical trial sites, number of subjects, and type and frequency of procedures and assessments are important cost drivers and providing them will help ensure a more accurate proposal.  Also, an experienced CRO should also be able to make valuable recommendations based on your protocol.
  3. Provide detailed RFP information to get consistent costs. Be specific. Some examples might include:
    • Project specifications – What are the important details of your program? (Use our RFP specifications tool)
    • Project timelines – By when do you expect certain milestones to be met?
    • Responsibilities (CRO, sponsor, other vendors) – For which segments of your program do you need a CRO to provide clinical trial services?
  4. Provide additional details. The more details you can provide the better.  It’s also OK to ask questions of prospective CROsask the CRO to make recommendations. You can tell a lot about a CRO by the recommendations they make and how they make them.  However, if you ask CROs to make recommendations be prepared for potential inconsistencies in the assumptions made and pricing offered between different CROs. The following are some additional details that might be helpful to bidders:
    • Provide site locations if you have already determined which sites you want to use.  If you aren’t sure, ask for recommendations based on your target enrollment and timelines.
    • If you’ve already determined which sites you’ll be using, it is helpful to know whether they will use a central lab or local lab and also will they use a local or central IRB. This can have an impact on timelines and costs.
    • Make note of any additional vendors you need such as specialty labs, Electronic Patient Reported Outcomes (ePRO), translations, meeting planners, or imaging services.
    • Will you be using paper or EDC? The vast majority of trials are now using EDC, but there may be some small studies or specific circumstances where paper still makes sense.
    • Do you want your data output in CDISC format? Based on the FDA’s guidance, new studies must be submitted in CDISC format, so it is strongly recommended.
    • If you are planning an interim analyses or will need support for a DSMB, make sure to include this information.
    • Will you use automated subject randomization (IVRS or IWRS)?
    • What are your plans for clinical supplies and distribution (IP management)?
    • Are you interested in risk-based monitoring strategies?  If so, include this information in your RFP. Incorporating remote monitoring or targeted SDV strategies could impact the budget.What are your plans for clinical supplies and distribution (IP management)?
    • Do you want the CRO to be responsible for the TMF?  If so, ask about whether they use an eTMF and if so which one.
    • If you know you want to use specific vendors (i.e. you know you want to use Medidata RAVE for EDC), be sure to include that information.
  5. Other items to request from CROs:
    • Project team CVs including the project manager, lead CRA, lead data manager, medical monitor, and lead statistician
    • Summary of team therapeutic experience and experience running similar trials
    • Relevant company information
Download: RFP Specifications Tool

 

How Stable Is Your CRO?  And Does It Matter?

Posted by Brook White on Wed, Feb 01, 2017 @ 11:15 AM
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CRO stabilityClinical trials are a costly business.  In 2013 alone, the biopharmaceutical industry spent nearly $10 billion on clinical trials.  Operational failures in clinical trials can increase those costs and create delays in time to market. So when you pick a CRO, you want to ensure that at best they are mitigating operational risks, and at worse aren’t introducing new ones. Stability can play a significant role in this.

Corporate stability

When looking to outsource to a CRO, there are several aspects of corporate stability that should be assessed:

  • How long has the CRO been in business? The newer the company, the more likely that they don’t have the overall experience you may need. Additionally, they have a shorter history with their clients, so it will be difficult to assess past customer satisfaction.
  • Are they financially stable? A company that isn’t profitable, has a lot of outside debt, or is under strain from shareholders or investors may be making short-term business decisions that aren’t in the best interests of your study or program. Worse yet, they could go out of business in the middle of your clinical study or run into cash flow issues that impact the success of your clinical trial.
  • Have they recently been involved in M&A activity, have they gone public, or are there plans to do so? This type of activity typically comes with significant organizational impacts that can bleed over into day-to-day activities. From changing SOPs mid-study to project team turnover, it rarely has a positive impact in the short-term for existing clients.

Consider incorporating questions about these topics into a request for information (RFI) or as part of the request for proposal (RFP) process.  These are valid questions that CROs are used to addressing, so be wary of companies that are reluctant to do so.

Client Stability

client stabilityA good measure of how well you will be treated once the contract is signed is the satisfaction of existing and former clients.  You should look for a CRO that has long-standing relationships with many of their clients.  You’ll often see CROs that have slides listing the logos of their clients or with testimonial quotes from clients.  That’s all well and good, but you need to check for yourself.  Ask for references whose work is of similar scope and for similar services as those you are planning to outsource.  Contact references directly rather than relying on the CRO to act as an intermediary.

People Stability

happy project teamEmployee turnover rates across the CRO industry are incredibly high. In 2015, CRO turnover was 25% despite the fact that team stability is a key factor in meeting sponsor expectations and in doing high quality clinical research. Make sure you ask both about turnover and about the tenure of your assigned team. A team with multiple members that have recently joined the company should be a red flag. In addition to company turnover, find out what you can about project team stability. Keeping a team together over the course of a study means less re-training, fewer mistakes, and less re-work. There is a learning curve with each new sponsor and product. If you are considering outsourcing multiple trials particularly within the same program, ask if the same team members can be assigned to future studies.

Learn more about selecting a CRO by checking out the outsourcing tips on our blog.

Download: RFP Specifications Tool

Top Trends in Drug Development from This Year’s DIA Annual Meeting

Posted by Brook White on Tue, Jul 12, 2016 @ 02:41 PM
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During the last week of June, the Drug Information Association held its 52nd Annual Meeting in Philadelphia.  As one of the largest conferences in our industry, DIA covers a wide range of topics over the entire spectrum of drug development, and it would be nearly impossible to provide a comprehensive accounting of the meeting.  However, I will try to share the most notable trends and themes from the meeting.

Big Data

big data in drug developmentBig data was possibly the hottest topic this year.  Not only did FDA Commissioner Dr. Robert Califf participate in a panel session on the topic, but when listing his top four priorities, one of them was greater use of existing data in EMR/EHR systems.  At DIA, people were really talking about big data from a handful of sources—electronic medical records data, data from wearables, data from social and digital media and genomics (and other -omics) data.  FDA is taking a lead role in the use of big data and real world evidence through initiatives like Sentinel, which enhances the FDA’s ability to proactively monitor the safety of medical products on the market, and precisionFDA, a community platform for next generation sequencing (NGS) assay evaluation and regulatory science exploration.  Big Data is an idea that has been talked about for some time, but based on this year’s meeting it is clear we’ve moved beyond idea to reality.  For anyone wondering how soon we might see full genomic sequencing of all patients in a clinical trial, you will be interested to learn that the cost is now on par with a chest x-ray, Genentech has sequenced 30K genomes to date, and AstraZeneca recently entered into a partnership with Human Longevity to sequence 500K genomes over the next 10 years.

Patient Centricity is Still Big

patient-centricityPatient centricity was the theme of last year’s meeting, and continued to play a central role in this year’s meeting.  But while last year was big on ideas and optimism, this year saw early adopters sharing lessons learned from programs already up and running.  Patients and patient advocacy groups made up a noticeable group of attendees and were outspoken during sessions.  Several companies including Bristol Myers Squibb (BMS) and GlaxoSmithKline (GSK) shared specific programs and tactics they’ve been using to move to a more patient focused research model.  Some examples include creating frameworks that allow greater number of employees to engage with patients and the public about the work they are doing and developing minimum standards for patient engagement that reflect geographic and cultural differences.  From a regulatory perspective, patient-centricity made Dr. Califf’s list of his top four priorities.

7 Tips to Use Social and Digital Media to Recruit and Engage with Clinical  Trial Patients

The Swinging Pendulum on Outsourcing

swinging pendulum on outsourcingFor many years now, it seemed the trend was always to more and more outsourcing with innovator companies keeping fewer and fewer activities in house.  Several of this year’s outsourcing sessions are hinting that the pendulum on that trend may be starting to swing back.  From internal frustrations with outsourcing groups, to dissatisfaction with vendors in terms of both quality and performance, to the failure of preferred provider relationships to deliver on expected savings and improvements, the talk from a number of pharmaceutical and biotech companies is that they are keeping more work in-house. That said, there certainly is not agreement among sponsors or vendors/suppliers on this issue.  Many pointed to issues at sponsor companies such as refusal to hear feedback from CROs on the feasibility of their budgets, timelines, or study designs as well and disagreement between outsourcing personnel and study team personnel about the providers being selected.

Drug Development as a Calling

DIA opened with keynote speaker Dr. Larry Brilliant, a physician and epidemiology who participated in the World Health Organization’s (WHO) successful small pox eradication program.  Dr. Brilliant talked through a number of health research and outreach efforts that have dramatically changed the world for the better, including the small pox and polio eradication programs, the development of electrolyte solutions to treat cholera and diarrhea, and more recently the efforts of the Carter Center to eradicate guinea worm.  He brought into sharp focus the idea that what each of us in the pharmaceutical industry does has the potential to change the world for the better.  The idea of drug development as a calling was furthered by Dr. Califf’s call to all of us to donate the information in our electronic health records for the betterment of research and medicine—a reminder that we should be willing to open ourselves up in the same way that we ask patients and research participants to do.  Finally, several of the patient-centricity speakers focused on the value of identifying employees who themselves were patients or care-takers of patients in their private lives in addition to being part of the research and development process.  These people are uniquely qualified to help us better understand the patients’ needs and experiences.

Greater Engagement by FDA

Finally, it was interesting to me to see the level of participation by the FDA in this year’s meeting. While they always send some presenters and a larger number come just to attend, this year did seem different. Dr. Califf presented in multiple sessions and was open and engaging during Q&A sessions. Additionally, numerous sessions included speakers and panelists from the FDA providing valuable insight into their point of view.

Did you attend DIA this year? If so, let me know what you thought.

Craftsmanship in Clinical Trial Study Design

Posted by Brook White on Wed, Jul 06, 2016 @ 02:55 PM
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Ryan Bailey, Senior Clinical ResearcherRyan Bailey, MA is a Senior Clinical Researcher at Rho.  He has over 10 years of experience conducting multicenter asthma research studies, including the Inner City Asthma Consortium (ICAC) and the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) project. Ryan also coordinates Rho’s Center for Applied Data Visualization, which develops novel data visualizations and statistical graphics for use in clinical trials.

Shann Williams, Senior Director OperationsShann Williams has 10 years of experience managing clinical trials. She is a Sr. Director of Operations and the program director of the statistical and clinical coordinating center of the Transplantation Group for the division-wide consolidated coordinating center sponsored by the National Institute of Allergy and Infectious Disease (NIAID).  In addition, Shann serves as Rho's project management operational service leader, an internal expert sharing project management best practices, processes and training.

My dad is an expert carpenter and handyman. Growing up, I spent hours watching him work - furniture, flooring, painting, plumbing, roofs, siding, decks - you name it, he did it. I learned a lot from watching him and helping him, but I never accomplished his level of expertise and proficiency. It is not for lack of knowledge or ability; rather, it is a lack of practice and experience. I'm capable. My father is masterful.

craftsmanship in clinical trial study designClinical trials are not so different from construction and craftsmanship. To be a successful clinical researcher, you need to coalesce expertise across a variety of domains - statistics, data management, project management, clinical operations, product safety, regulatory, medical writing - as you design, prepare, execute, and troubleshoot throughout the trial. The CRO industry exists because we provide specialty expertise in these areas, and many pharmaceutical companies are glad to have a trusted partner to manage various aspects of this work.

Yet, regardless of which CRO services pharmaceutical companies seek out, one task pharmaceutical companies have been reluctant to source to their CRO partners is clinical trial design. According to a recent press release by Cutting Edge Information, as recently as 2014, no Top 50 pharmaceutical or medical device team surveyed reported that they shared clinical trial design responsibilities with CROs.

This is not especially surprising. With their product on the line, pharmaceutical companies have a keen interest in retaining careful control over the study design. It is also a matter of practicality. Before seeking out a CRO to support management of your trial, it helps to have a well-constructed plan of how the trial should be executed. However, Cutting Edge Information reports that this trend is likely to change dramatically in coming years. By 2020, over 50% of companies they surveyed plan to share trial design responsibilities with CROs. Why the change?

In part, it's due to the need for craftsmanship. When it comes to clinical trials, CROs offer a level of end-to-end proficiency built on decades of extensive trial management experience and specialization. When your job is conducting hundreds of trials for a wide range of clients and diverse therapeutic areas, you naturally achieve a high degree of expertise: a deep knowledge base, valuable foresight, honed skills, improved efficiencies, and the ability to operate deftly in a complex and highly regulated environment. As the ones most often implementing the trials, overseeing the day-to-day project operations, and conducting analyses, CROs are in the best position to identify the strengths and weaknesses of clinical trial designs.

With the pace of new drug and device development lagging, costs increasing, and pressure to get efficacious products to market building, clinical trial designs have come under growing scrutiny. Bad blue prints lead to less than optimal functionality or worse: a complete do-over. In the same way, even simple trial design errors will lead to less than optimal results. The need for a do-over can be cost-prohibitive or just plain disastrous.

By incorporating CROs in the design process, pharmaceutical companies will foster closer partnerships, reduce costs by leveraging efficiencies, benefit from the extensive experience CROs have to offer, and craft more effective trials. Independently, pharmaceutical companies and CROs are capable. Together, we are masterful.

Free Webinar: Protocol Design

5 Ways Rho Keeps Employee Turnover Low

Posted by Brook White on Wed, Jun 22, 2016 @ 11:40 AM
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Employee turnover rates across the CRO industry are incredibly high.  In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs.  At Rho, we recognize that team stability is a key factor in meeting our Sponsors’ expectations and in doing high quality clinical research.  In order to maintain team stability, we have to keep employee turnover low—significantly lower than industry average.  How do we do that?

Company Culture

As is frequently said by Rho co-Founder Ron Helms, the goal should be that we are all happy at work 19 days out of 20.  While everyone has an occasional bad day, we strive to make Rho a place where people are excited to come to work each day.  For starters, we have an intensive hiring and on-boarding process that ensures that people who come work here will be a good fit here.  Every prospective employee is interviewed by a senior leader whose job it is to protect the culture we’ve built.  It is amazing how much more enjoyable work is when your co-workers are smart, fun people who are good at what they do.

Rho game roomThe physical work environment is important too.  We constantly look for ways to improve the work environment.  Recently, we’ve added a game room with TVs, video games, and ping pong; the RhoHUB which is a central gathering place for co-workers to grab a cup of coffee or sit and eat lunch from one of the food trucks; and a meditation room.  All employees have the option of a standing desk, and we’ve experimented with some other alternative arrangements like treadmill desks and stationary bike desks.

We also encourage employees to connect with the community at large.  Last year, in addition to a significant corporate gift to DonorsChoose.org, each employee received a gift card to donate to a classroom or school project of their choosing.  Each year, we have a BBQ and raffle fundraiser to support the March of Dimes and numerous employees participate in the March of Dimes Walk for Babies.

Finally, no discussion of Rho’s corporate culture would be complete without mentioning our core purpose and core values.  Our core purpose is to improve health, extend life, and enhance quality of life via corporate and research excellence.  Our core values are integrity, stability, innovation, quality, to think critically & creatively, profitability, agility & adaptability, a team culture, and great people.  These aren’t just words on paper—they regularly come up in meetings and are used in decision making.

Competitive Compensation and Benefits

This probably goes without saying, but offering competitive compensation and benefits is a crucial component of any employee retention plan.  We regularly review market data on salaries to ensure not only are we bringing people in at appropriate levels, but that throughout their tenure here employees’ compensation keeps pace with the market.  We also offer a generous benefits package that includes standard stuff like healthcare and retirement plans, but also some nice perks like a concierge service that runs personal errands for employees.

Opportunities for Growth and Advancement

project meetingRho has a comprehensive career path system that is designed to reward both the breadth and depth of skills that employees acquire during their time here.  We encourage all employees to explore areas outside their existing area of expertise because it makes them more valuable to Rho and more valuable to our clients.  We prefer to promote from within when possible, and the majority of our senior leaders came into their current positions this way.  Entry level employees are exposed to a broad set of functional areas and skill sets, and most spend at least a year or two in generalist roles before becoming more specialized in an area of interest.

Work-Life Balance

Rho fitness centerWe believe our employees are most effective at work when they have a fulfilling life outside of work.  In a world where many people never disconnect, we discourage checking email at night and on weekends unless truly necessary.  We want people to take real vacations where they don’t take work with them, call into meetings, or constantly respond to email.  We also realize that life requires flexibility, and we trust employees to make good decisions when setting their hours or deciding to work from home rather than come into the office.

Work That Matters

Last, but definitely not least, is the opportunity to do work that matters. The research we do solves real problems. From breakthroughs in preventing peanut allergy, to getting a new product to market that extends the lives of cancer patients, to life changing improvements for organ transplant recipients, Rho employees know that the work we do here matters.

Free Webinar: Optimizing Sponsor/CRO Relationships

4 Reasons Low Employee Turnover Is Critical in CRO Selection

Posted by Brook White on Fri, Jun 03, 2016 @ 11:48 AM
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Employee turnover rates across the CRO industry are incredibly high.  In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs.  As a Sponsor selecting a CRO, why should this matter to you?  The higher a CRO’s employee turnover rate, the more likely that team members assigned to your study will change over the course of the project.  Project team stability can have a significant impact on the quality of execution, ability to meet timelines, the amount of time and energy you will need to put into oversight, and site relationships. While no CRO can guarantee zero turnover on your team, the ideal situation is that the team you meet during the selection process will be the same team present during study start-up and the same team at project close out.

Quality

quality.jpgClinical studies are complicated.  Over the course of a study, team members become entrenched in the details of the study—understanding the protocol, knowing the details in study plans like the data management plan and the clinical monitoring plan, and participating in investigator meetings and other study specific training.  As a result, things run smoothly.  Problems are less likely to be missed, risks are identified earlier, and fewer errors are made.  There is a human aspect as well.  CRAs that have a chance to develop relationships with their sites are more likely to catch on when something is amiss.  They know which sites may need a little more attention to keep up with enrollment projections.  Strong working relationships between functional area leads mean smoother hand-offs as well.  When the data manager and biostatistician have been working together from the outset, there are fewer surprises when it comes time for database lock.

Timelines

time is moneyNew team members mean additional training, time spent reviewing study documents, and time getting up to speed on the study.  Even if it is a fixed price contract so there is no direct cost impact, the additional time spent on team member transitions may very well impact key milestones.  

Increase in oversight

oversightYour time is valuable.  As a Sponsor, you have a responsibility to provide oversight for your study.  With a stable team and proven track record, it is likely that over the course of the study you can back away from the level of oversight you are providing—how much time you spend reviewing status reports, how much detail you need in your reports, how frequently you meet with your CRO.  However, when key team members leave and new ones are added, the risk increases which means your scrutiny needs to increase.

Site relationships

handshakeSites that meet their enrollment projections and produce high quality data are crucial to the success of your clinical trial.  Consistent communication and strong relationships with their assigned CRA are needed to get the best performance out of your study’s sites.  If their CRA or other main contacts keep changing, it is hard to build and maintain those relationships.

Given that low turnover is so important, what can you do?  When it comes time to select a CRO for your next clinical study, make sure to ask about turnover rates, and specifically, about CRA turnover.  You should look for a CRO with an overall turnover rate around 10% and a CRA turnover rate of less than 15%.  Pay particular attention to the longevity of key team members.  Look for a team where most of the key team members have been with the company at least 3-5 years.  Finally, talk to prospective CROs about what they are doing to ensure team stability and how they will handle any turnover that happens during your project.

5 Tips for Creating an RFP

4 Top Trends in Drug Development: DIA 2015 Recap

Posted by Brook White on Tue, Jun 23, 2015 @ 11:04 AM
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Last week, the Drug Information Association held its 51st Annual Meeting.  As one of the largest conferences in our industry, DIA covers a wide range of topics over the entire spectrum of drug development, and it would be nearly impossible to provide a comprehensive accounting of the meeting.  However, I will try to share the most notable trends and themes from the meeting.

Patient-centricity

patient-centricClearly, one of the biggest take-aways from DIA was patient-centricity. While for many of us patients have long been the motivation for the work we do, patients now are playing a central role throughout the drug development process. In addition to their roles as patients in clinical trials and eventual consumers, patients increasingly are participating in all aspects of development, from study design to advisory committee meetings. As we make this transition, patient advocacy groups can be powerful allies in reaching out to patients.

Some keys to patient outreach and involvement are relevance, logistics, and psycho-social components. For patients to be on-board with trials, they need to understand why a study is relevant. Patients need to see the link between how their participation now can lead to improvements in treatment in the future. Often, patients are interested in the outcomes past their own participation. Keep them updated as trials complete and results are available.

Patients can also provide useful insights on logistics. What may seem like minor considerations to scientists and others involved in study design, could be significant when it comes to patient participation. Logistics around scheduling, childcare, and uncomfortable procedures can be a study’s downfall if patients aren’t willing to sign-up or eventually drop-out because of inconveniences.

There are psycho-social issues that should be considered for certain patient populations and conditions. For example, it is likely that diabetics would have little concern over using an injectable treatment. Many have already used injectable products or have at least considered the need to use them in the future. On the other hand, patients used to oral dosing may have objections.

Finally, one suggestion made by a patient advocacy group at the meeting was to have all members of the clinical study team spend a day with a patient from the population being study. Understanding their daily routines and struggles can provide important insights.

Social Media is Big—And Getting Bigger

social media and drug developmentNearly every track featured at least one presentation on social media. We are now moving past theoretical uses to real world applications in patient recruitment, medical information, safety monitoring, and even regulatory agencies.

Use of social media is becoming commonplace in patient recruitment. In addition to being a more cost effective option when compared to traditional media like broadcast, radio, and newspaper ads, it also allows for better targeting and reporting. For example, social media allows you to show ads only to those within appropriate demographic groups. Even demographic groups previously considered poor targets for social media, like the elderly or lower income populations, are increasingly online in one way or another. Additionally, Sponsors and CROs have largely found ways to address regulatory and privacy concerns.

Medical Information is another area where social media use is increasingly common. With several FDA guidance documents now in place, Medical Information professionals’ perspectives on social media are changing. Patients making contact with pharmaceutical companies are being seen less as a risk to respond to and more as an opportunity to engage proactively. While companies should still be careful to present scientifically-based balanced information, social media can provide an opportunity to correct faulty information and even respond to questions about off-label use in a non-promotional way.

Safety monitoring is another area primed for growth in social media use. With the question of how to deal with adverse event reporting through social media largely handled—be prepared for it and treat it the same way you would treat reports coming in through traditional channels—product safety professionals are turning their attention to ways they can use social media to improve patient safety. Dr. Ran Balicer of the Clalit Research Institute is pioneering a system to identify safety signals in social media and compare it to information being reported by clinicians and to regulators.

Regulatory agencies are embracing social media as well. FDASIA Section 1138 instructs the FDA to create a communication plan to better inform and educate consumers with a focus on communicating with underserved sub-groups. The working group at FDA is relying on social and digital media to build the core of this program.

Outsourcing Trends

Despite incredible growth in outsourcing over the past 20 years, Sponsors still struggle with the right balance of outsourcing models. Both Sponsors and CROs report dissatisfaction with outsourcing relationships. Strategic relationships aren’t delivering the promised cost and time savings. The number of companies entering into strategic alliances and functional service provider relationships has been steadily growing over the past few years, yet virtually all Sponsors admit that they are still making outsourcing decisions (full service, FSP, or niche providers) on a study by study basis.

key performance indicatorsOne major challenge identified by several speakers is the ability to select key performance indicators (KPIs) that both accurately measure the CROs performance and those for which CROs are prepared to provide the data necessary to produce the metric. Existing KPIs have largely been selected because they are easy to measure and report on regularly, but they are often a better measure of the study design and the Sponsor’s ability to manage the relationship than they are a measure of the CROs performance. However, ability to produce metrics and willingness to be transparent continue to be make-or-break for Sponsors when it comes to selecting preferred providers, entering into strategic alliances, and picking functional service providers.

eSource, eTMF, and Risk-Based Monitoring

Perennial favorites, there was no shortage of presentations on the topics of electronic trial master file (eTMF) solutions, eSource and electronic data capture (EDC), and risk-based monitoring. Although eTMF has been a hot topic for a number of years, adoption is still slow. Many companies are considering implementing an eTMF, but most are still using paper systems, network file systems, content management systems, or a combination. However, growing Sponsor expectations for remote access to TMF documents combined with improved audit readiness will continue to push CROs in this direction.

risk-based monitoringOn the other hand, risk-based monitoring has become a reality for many studies. Companies have been investing in tools and processes and regulators continue to show support. As a result, more studies are taking advantage of the benefits of risk-based monitoring.

Although it has seen widespread (and in some instances near complete) adoption, EDC has left many feeling it hasn’t lived up to expectations. It hasn’t reduced significantly the cost or time of trials. Because much of the information clinicians need to record during study visits isn’t recorded in the CRF, information is still being recorded in one place and then transcribed into EDC. eSource—a combination of ePRO tools, EHR/EMR integration with EDC, and other electronic sources—offers new hope to deliver on the original promise of EDC.

Were you there? If so, use the comments to let me know what you thought were the most important take-aways from DIA this year.

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5 Reasons Your CRO is Putting Your Trial at Risk

Posted by Brook White on Mon, Mar 10, 2014 @ 09:44 AM
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Information for this article was contributed by Alicia McNeil and Elizabeth Kelchner, Clinical Data Scientists at Rho with significant experience in rescue studies.

warning signs in clinical trialsNo one wants to be here: You went through a lengthy proposal process, endured the bid defense process and thought you selected the best CRO for your study. The contract is signed and the study has started, but things just don’t seem right.

Here are five red flags to watch for if you suspect problems with your CRO, as well as tips for what to do if you decide your study needs to be rescued.

  1. You loved the team you met at the bid defense meeting, but once your study started you were assigned a completely new (and less experienced) team.
    Some new assignments are always a possibility. Maybe one of the team members left the company or a team member was unavailable because a study that they anticipated would be complete ran over. That said, you shouldn’t see substantial turnover on your team, and replacement team members should have similar experience and expertise to those you met at the bid defense.
  2. Project team members don’t return your calls or respond to email in a timely fashion.
    You can’t expect your project team to sit at their desks all day to answer the phone and check their email. After all, they need to be busy working on your project. So what is a reasonable amount of time to wait for a response? Hopefully, they’ve set clear expectations for response times during the kick-off meeting and in the project management plan, but one business day is a typical benchmark for non-urgent communications. There also should be a process and expectations in place to deal with time critical issues.
  3. You haven’t seen and haven’t been asked to sign off on important study documents.
    There are a variety of documents that the CRO should draft during study start-up (project management plan, clinical monitoring plan, data management plan, etc.). You should be given the opportunity to provide input, review, and sign off on these documents as they will set the direction for the execution of the study and ensure expectations are set on all sides.
  4. You aren’t receiving regular status reports.
    Status reports are another topic your project team should have covered at the kick-off meeting and in study documents so that you know what to expect in each area for which the CRO has contracted responsibility. They should be sending you status reports in a consistent format on a regular schedule. The reports should include enough detail that you can track the progress of important activities and gauge any significant risks to the study.
  5. There are signs data isn’t being collected or managed properly.
    In a study that is running smoothly, you should expect to see the following in terms of data collection and management:
    • Data is being collected in a system designed to handle clinical trial data. If data is being collected in spreadsheets or another unorthodox manner, this is a very significant problem. This may seem obvious, but more than once we’ve rescued studies where data was being collected into Excel spreadsheets.
    • You are given the opportunity to participate in User Acceptance Testing (UAT) if your study is using EDC. This is a good way to familiarize yourself with the specifics of how data is collected and what sites will experience, and it demonstrates transparency on the part of the CRO.
    • Queries are being sent and closed on a regular basis. As soon as sites start collecting data, you should be getting updates about queries sent and closed.

Sometimes, despite your best efforts to correct course with your CRO, you may decide that you need to change CROs mid-stream.  Here are some tips for interacting with your existing CRO before and during the transition as well as tips for selecting a CRO to rescue your study:

Tips for working with the incumbent CRO:

  • Keep copies of all documentation (study plans, annotated CRF, build specifications, decision logs, etc.) in case you need to transition to another CRO. Don’t rely on the incumbent CRO to do this. The more historical information available to the new CRO, the better.
  • Get regular data transfers.
  • Request and implement a communication plan. Know how to escalate issues if needed.
  • Have regular meetings with all team members to keep everyone on the same page. If possible, meetings that include both members of the incumbent CRO team and the rescue team can make the transition much smoother.
  • Avoid burning bridges with the incumbent CRO early in the process.
  • Negotiate the financial side of transitions carefully so that the incumbent CRO can work as necessary to complete tasks where practical given timeline constrains as opposed to relying on the new CRO to complete all tasks. This also allows appropriate communication between the incumbent and the new CRO.

rescue trialsTips for Selecting a CRO for the Rescue

  • They should have a thoroughly documented rescue process or rescue project plan template.
  • They’ve successfully implemented rescues between the applicable platforms (i.e., EDC to EDC, paper to EDC, EDC to paper).
  • They understand the need to minimize and manage process change for clinical trial sites.
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Which Type of Contract is Right for your Clinical Research Project?

Posted by Jamie Hahn on Mon, Nov 05, 2012 @ 10:02 AM
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contracts 101You've chosen a contract research organization (CRO) to partner with on your next clinical research project or program, and now it's time to sign a contract. It's important to be familiar with the different types of contracts and payment schedules, so that you can have an open discussion with the CRO about which is the best fit for your company and your project. It's always ideal to put a contract and payment schedule in place that is mutually beneficial for the CRO and the Sponsor.

The following is a description of the different types of contracts and payment schedules and when it's best to use each. 

Milestone Based Fixed Price Contracts

These are very typical contract forms which are used frequently for clinical research projects. As the name implies, the CRO offers the client a fixed price to complete the agreed upon scope of work. Therefore, if the CRO spends more hours than expected to complete a task, the CRO absorbs those additional costs.

If the scope changes, both parties agree on a price increase or decrease for the change. These contracts are referred to as milestone contracts because the payment schedules are made up of dollar amounts associated with pre-negotiated “milestones.” A billing occurs each time a milestone is achieved. For instance, in a contract that includes clinical monitoring, one of the contract milestones might be “Upon 50% Enrollment” - $X. In this case, we would bill $X on the date that 50% of the patients are enrolled in the study.

These contracts are generally used when the scope of work is well defined between the CRO and the sponsor, and the sponsor wants to have a high degree of certainty related to its necessary cash outlays.

Variable Price Fixed Unit Contracts

Unlike milestone based fixed price contracts, the total price of a unit based contract may vary. However, a fixed cost is agreed upon for all defined units. For instance, if the CRO is providing biostatistics services, they may agree to a price of $10 for each unique table that is delivered.  In addition, they may estimate that they will provide 10 unique tables for a total price of $100.  If during the course of the study, the client realizes that they will need 12 unique tables, they would be billed $120 without preparing a contract amendment.

Variable price fixed unit contracts are particularly useful when the scope of the contract may expand or contract based upon outcomes of the study.

Time and Materials Contracts

These are the simplest form of contract. In time and materials (T&M) contracts the CRO bills for actual hours at agreed upon rates. The roles and rates are defined in the contract. As an example, if a Clinical Data Associate (CDA) works for 10 hours on a T&M project and the agreed rate for a CDA is $10/hr, the client would be billed $100 dollars. T&M contracts generally have a contract cap that defines the limit of dollars that can be billed under that contract.  

Time and materials contracts are very useful when the scope of the project is undefined.