Jan. 2, 2018: Innovations to Increase Participation in Clinical Research

Every person with an illness wants the best treatment available, and given the pace of biomedical research, that best treatment may be new or even still under study. And Americans are well-known for their attraction to the “new!”, believing that new likely means better. It is curious, therefore, that only a small number of people with any disease — generally less than 10 percent — participate in clinical trials of new treatments. This lack of participation greatly increases the time and cost of clinical testing of new interventions and regularly delays or prevents new treatments from being approved. One particular issue, given the increasing diversity of the U.S. population and the advent of precision medicine, is our inability to enroll enough diverse participants to adequately represent the U.S. population or the subpopulation for which an intervention is being developed. Too often, an investigator simply cannot find enough volunteers who meet the trial criteria and must either find additional resources to boost study recruitment efforts or cancel the study.

Put simply, our increasing recruitment failures threaten to choke off translational progress. As a result, NCATS has designated recruitment innovation as one of its top priorities.

A centerpiece of our efforts is the Clinical and Translational Science Awards (CTSA) Program’s Recruitment Innovation Center (RIC), a part of the CTSA Program Trial Innovation Network. Researchers at the RIC, which is based at Vanderbilt University with connections to all the CTSA Program hubs, are developing and disseminating best practices for engaging and recruiting participants, particularly from communities traditionally underrepresented in clinical research.

Through the CTSA Program’s Accrual to Clinical Trials (ACT) initiative, researchers are forming a national network of sites that will use electronic health record (EHR) data to identify potential participants. Since health care systems vary widely in how their EHR data are organized, searching across institutions for eligible patients has been a persistent challenge. ACT investigators are working with widely used open-source technologies to enable a qualified researcher to search for eligible participants while protecting patient privacy and meeting all legal and ethical requirements.

I also am excited about the Strengthening Translational Research in Diverse Enrollment (STRIDE) initiative, a collaboration among three CTSA Program hubs to develop and test innovations to increase participation of underrepresented groups, including African Americans and Latinos, in clinical trials and other research efforts. STRIDE tools will include culturally, linguistically and literacy-tailored recruitment and informed consent protocols. Once the innovations are shown to be effective, STRIDE investigators will disseminate the tools broadly so that anyone can use them to improve recruitment diversity for clinical trials and other translational research.

Through these and other efforts to increase participation in research, NCATS is both accelerating translation and ensuring that its benefits reach all who need them.

Christopher P. Austin, M.D.
Director
National Center for Advancing Translational Sciences