June 25, 2015: Innovating in Multisite Clinical Trials
Although a great deal of painstaking work goes into creating and testing potential new treatments before they are administered to people, the most critical and complex stage of the translational process is the testing of interventions in humans for safety and effectiveness. Because these “clinical trials” often require testing in large numbers of people with a particular type of disease, multiple hospitals or other clinical sites usually are needed to study the intervention in a sufficient number of patients in a timely fashion. Similarly, large observational research projects such as cohort studies typically require the collaboration of multiple clinical sites.
Unfortunately, scientific and operational problems currently limit the pace of multisite studies, leading to delays, failures and costs that ultimately slow or prevent treatments from reaching the people who need them. Among other challenges, failures in participant recruitment and delayed trial commencement due to duplicative institutional review board (IRB) reviews and contract negotiations frustrate researchers and patients alike.
NCATS is tackling these system-wide problems head-on in multiple ways, most notably via our Clinical and Translational Science Awards (CTSA) program. Our two recently released funding opportunity announcements — for Recruitment Innovation Centers (RICs) and Trial Innovation Centers (TICs) — aim to transform multisite clinical research for the benefit of patients.
Through the RICs, investigators will develop informatics-driven approaches to assessing the site-specific availability of potential participants during trial planning. These estimates will be based on de-identified, aggregated data derived from electronic health records at individual sites and across the CTSA consortium. Before and during the implementation phase of a clinical trial, the RICs also will collaborate with CTSA investigators to develop innovative strategies for engaging and enrolling research participants in a timely manner.
The TICs will provide innovative infrastructure to establish reliance IRB agreements that allow for the designation of a single “IRB of record” for a given multisite study. An IRB — composed of scientific, nonscientific and community members — must review and approve each new study to ensure that safeguards are in place to protect human participants from harm and that research is conducted ethically. With multisite studies, typically each institution’s IRB would need to approve the study. A single IRB of record removes this need and speeds the trial process. TICs also will offer streamlined contracting to accelerate study start-up.
Working together and across the CTSA hubs, the RICs and TICs will facilitate continuous improvement in research participant recruitment and study conduct across the CTSA network. The RICs and TICs will disseminate these approaches to the larger research community as well.
In conjunction with the collaborative opportunities I discussed last month, these two new funding opportunities will help NCATS continue to evolve the CTSA program to address major roadblocks to efficient translation. The goal is to enable the scientific community to dramatically accelerate the process of translation and, most importantly, get more treatments to more patients more quickly.
Christopher P. Austin, M.D.
National Center for Advancing Translational Sciences