April 5, 2018: Practice Makes Perfect — “Good Clinical Practice” Makes Perfect Sense for Researchers

Given that translational science is such a young and growing field, NCATS places emphasis on training and workforce development. Until very recently, no one — myself included — trained to be a “translational scientist,” since the discipline did not exist. Translational science shares this characteristic with other new and exciting fields, such as data science. I have previously written about NCATS’ extramural and intramural trainee programs, our Assay Guidance ManualToolkit for Patient-Focused Drug Development, and international educational efforts, all of which aim to give those new to translational science the knowledge and skills they need to be contributors to the translational team.

As readers of this column will know, studies of diseases and treatments in people are the lynchpin of translation but present many scientific and logistical challenges that are currently limiting efficiency and effectiveness. One reason for the persistence of these challenges has been the heterogeneity in practices of investigators conducting studies in humans. To tackle this issue, NCATS Clinical and Translational Science Awards (CTSA) Program investigators, led by the University of Michigan, collaborated to enhance, streamline and standardize training in clinical research processes across the consortium. These research processes are termed “good clinical practice” (GCP) by analogy to established standardized processes for the research laboratory (“good laboratory practice,” or GLP) and manufacturing (“good manufacturing practice,” or GMP). GCP is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical studies. These common standards can help ensure the integrity of the data collected, which in turn boosts confidence in research results.

The CTSA Program GCP team identified a need for training that addressed the unique aspects of clinical trials for behavioral interventions. Behavioral trials tend to pose lower risk to participants and are not regulated by the U.S. Food and Drug Administration. But they can be more complicated, taking place in a range of settings outside the clinic, such as in schools and homes or even online, where investigators have less control over the research environment. In addition, behavioral trials can be administered by personnel with a variety of backgrounds, from clinicians to social workers to community leaders. Some aspects of traditional GCP training were not relevant to behavioral research, while other unique issues were not covered at all.

To solve this systemic problem, the CTSA Program team developed an e-learning course that applies GCP principles to social and behavioral research. The course was initially disseminated throughout the CTSA Program consortium, and it is now available through the NIH Office of Behavioral and Social Sciences Research. It has been adopted by professional organizations such as the Society of Behavioral Medicine and by the NIH Common Fund’s Science of Behavior Change program. Moreover, the Collaborative Institutional Training Initiative, a leader in certifying researchers in GCP, has now integrated the training into its offerings. GCP certification is now required for every investigator and coordinator working on an NIH-funded study involving human participants.

The GCP project is a notable example of NCATS’ “3 Ds” in action. We supported development of the GCP training for behavioral intervention trials as well as testing to demonstrate its usefulness, and we have disseminated the training broadly to the social sciences and behavioral research community. I invite you to learn more about all our clinical research tools that are helping to improve health through smarter science.

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