This week I attended the 2017 ACRP Annual Meeting in Seattle. Here are some of the key trends, themes, and ideas that I took away. There were obviously far more sessions than any one person could attend, so I’m sure there are pieces I missed. If you attended, please feel free to add your thoughts to the comments below.
Core Competency Framework for Clinical Study Monitoring
One of the biggest announcements of the conference was that the Workforce Development Task Force and Steering Committee released a core competency framework for clinical study monitoring. The goal of the framework is to standardize professional expectations for individuals involved in clinical study monitoring. The framework is intended to define competency requirements for individuals involved in study monitoring regardless of experience level across eight domains—clinical operations/GCPs, communication and teamwork, data management and informatics, ethical and participant safety concerns, leadership and professionalism, medicines development and regulation, scientific concepts and research design, and study and site management. The core competency framework can be downloaded here.
ACRP Announces New Certification Program
ACRP announced a new certification program, ACRP-CP (certified professional). The new certification provides a non-role specific alternative to the existing role specific Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), and Certified Principal Investigator (CPI) certifications. The new credential seeks to formally recognize individuals with the skills, knowledge, and abilities to perform ethical and responsible clinical research regardless of their specific role. The first certification exam will be held this Fall.
Transparency and Flexibility from FDA
The first session on Saturday was a panel discussion with four speakers from FDA—three from the Center of Drug Evaluation and Research (CDER) Office of Scientific Investigations (OSI), and one from CDER Office of Integrity and Surveillance. As I commented following ACRP and DIA last year, FDA seems to be making a concerted effort to be accessible, transparent, and flexible in communicating with professionals involved in research. As a matter of fact, one of their stated strategic goals was stakeholder engagement (the others were user fee requirements, responsible stewardship, global context, and subject rights, safety, and welfare). They also stated that in places where existing guidance and precedence doesn’t exist and is needed to move research forward, drug developers should come to them with questions rather than waiting for formal guidance. In addition to the panel discussion, the three speakers who attended in person stuck around and held office hours Saturday and Sunday to talk to conference participants.
The panel addressed several questions that related to themes seen more broadly at the conference.
State of the Industry
Day 2 opened with a panel discussion on the state of the industry featuring ACRP President Jim Kremidas, Ken Getz from Tufts University Center for the Study of Drug Development (CSDD), Elisa Cascade, President of Data Solutions, Leanne Madre Director of Strategy for the Clinical Trials Transformation Initiative (CTTI) at Duke University, and ACRP’s Workforce Innovation Officer, Terri Hinkley. The panel focused their discussion on four broad forces impacting clinical trials:
Organizations involved in clinical trials are consolidating across the continuum. We are seeing both consolidation for economies of scale—CRO mergers and acquisitions, sites fusing into site networks—and vertical consolidation where organizations are increasing their capabilities—CROs buying site networks and central labs. It remains to be seen how this will impact clinical trials as a whole.
Datafication is the increased ability to gather and access ever increasing amounts of both structured and unstructured data that can be used in clinical research. The average phase III study now collected nearly 1 million data points. Additionally, we are seeing more data that is collected to drive payer and prescriber behavior rather than just to demonstrate safety and efficacy.
Integration refers to the efforts to better connect people, processes and technology. There are a number of national level initiatives to improve clinical research like CTTI, TransCelerate, and MDIC, a device and diagnostic initiative. These organizations have potential to move some agreed upon concepts from idea to reality. For example, both the NIH and the 21st Century Cures Act call for use of central IRBs, and CTTI is working on tools that can help make that happen. When it comes to technology, the perception is that the industry is suffering from “death by pilot.” People and organizations are willing to try lots of new technology, but consistent industry wide adoption is incredibly slow and lacking in standardization. Even EDC, which is hardly new or innovative at this point, is only used by 50% of studies globally. Common complaints and barriers include lack of consolidated platforms and the need to use different software and different login information for each study.
Uberization is moving research into healthcare in a way that works best for patients. There are greater pressures than ever to make research patient friendly rather than convenient for sites, PIs, CROs, and sponsors. Without patients, studies won’t happen. In this talk as well as others, there is a sense that patient centric practices aren’t just the right thing to do, they are necessary to succeed in research.
Finally, the panel identified key drivers for change over the next 3-5 years:
- Collaboration: Industry and CROs working together allow for standardization and process improvement.
- Regulatory willingness to try new things.
- The internet of things—devices in our lives provide access to information in new and objective ways.
- Technology that is easy enough to use that training isn’t necessary.
Innovating Clinical Trials with Mobile Technology
Day 3 featured a panel discussion on the CTTI mobile technology initiative. The initiative contains four working groups addressing:
- Mobile devices
- Novel endpoints
- Stakeholder perceptions
- Legal and regulatory issues
The goal is to provide evidence-based recommendations that allow an increased number of clinical trials to leverage mobile technologies.
One question they addressed upfront was the benefit of using mobile given the additional effort needed, and they provided four key answers:
- Potential reduction of burden on trial participants
- Increased patient access to clinical trials
- Availability of objective data
- Ubiquity of devices
The initiative has focused on studies conducted in the US, although they recognize it is a global issue. The stakeholder perception group is addressing concerns about security as well as concerns about losing the time and attention of the doctor providing care. The novel endpoints group is looking at new endpoints that are now possible to assess as well as existing endpoints that can be assessed more easily or more accurately than is possible with non-mobile technologies. The mobile devices group is looking at devices that can address existing challenges, data attribution concerns, and the identification of the difference between real needs to address research questions versus data fishing expeditions. The legal and regulatory group has its hands full with a variety of issues—understanding FDA’s willingness to accept mobile technologies, addressing privacy and confidentiality concerns, telemedicine challenges, dealing with IRBs, shipping issues, and reimbursement.
Finally, people were invited to engage in the process by signing up for updates or to participating in evidence gathering (firstname.lastname@example.org).
eHRs and Study Oversight
A significant concern expressed by auditors and monitors alike in a number of sessions is that site and institutions implementation of eHR systems do not provide adequate mechanisms for monitors and auditors to provide oversight. In some cases they are being provided with copies or printouts that are illegible rather than provided with direct access to eHR systems. In other cases, they are provided with access to eHR systems, but important information is sequestered. A common complaint is that sensitive records like those associated with mental illness, sexually transmitted infections, and substance abuse is are not being made available even when those records are relevant to the research and may reflect AEs. In one example, it came to light that a subject had attempted suicide while on an investigational product, but it was not initially reported as an AE and the study monitor was not allowed access to the record. With the increased use of eHRs in healthcare settings, this is not likely an issue to go away soon.
ICH E6 R2
Not surprisingly, many if not most sessions touched on the impact of the ICH E6 revisions and their impact to studies. Additionally, there was a two part session held specifically to review the revisions and discuss their impact. This is an extensive topic that is well discussed elsewhere, so I won’t go into detail here.
Importance of Conducting Ethical Research
While this isn’t new, ACRP continues to press the importance of conducting clinical research in ethical ways and expecting professionals involved in research to understand what that means. There were a number of excellent sessions on research misconduct and the relationship to public trust, ethical considerations in pediatric research, and recognizing vulnerable patients and patient populations.
Business Intelligence and Study Management
As the global volume of available data sources increases exponentially, those in clinical research are becoming more aware of the benefits of transforming these raw data sources into useful information for analysis purposes. The ability to effectively utilize the data we currently have depends on the thoughtful construction of metrics and key performance indicators (KPIs). The simple establishment of these types of measures must develop an even balance; a study can have too many metrics (which confuse the purpose), too few metrics (which offer weak benefit and minimal impact), or a focus that is too broad where one area grows strong at the expense of another. Other common pitfalls are underestimations of the time and effort required to combine various data sources, imbalances between metrics and action, and metrics that are developed for the sake of metrics. The development and use of these metrics and KPIs requires a cycle of continuous improvement: High-impact metrics must be identified and developed, accurate data gathered, and the lessons learned converted to actionable strategies and reassessed continually to correctly estimate our return on investment.
Thanks to Derek Lawrence for contributing to this article.