Expansion of “clinical trial” definition draws widespread criticism

Scientists, APA and other organizations seek to alter policy at National Institutes of Health.

A policy set to go into effect in early 2018 at the National Institutes of Health would expand the definition of “clinical trial” to include nearly all NIH-funded research with human participants, including basic behavioral and basic cognitive neuroscience research. 

In addition to requiring pre-registration of funded studies on ClinicalTrials.gov, the policy would impose extensive requirements for record keeping and training of laboratory staff that are appropriate for genuine clinical trials but neither necessary nor relevant for basic research. 

Labeling of basic research as “clinical trials” could also place applicants for NIH funding at a disadvantage because of restrictions on the types of grant mechanisms and review panels used for clinical trials.  For example, opportunities to apply for fellowships and training grants might be limited.  Eventually, the policy could result in a reduction in NIH support for basic research with humans.

Of further concern, inclusion of basic research on ClinicalTrials.gov could lead to confusion among the general public, including patients, about what kind of research counts as a clinical trial.

Background

The policy has its roots in a 2014 NIH notice (Notice of Revised NIH Definition of “Clinical Trial”, NOT-OD-15-15).  Although that notice states that it “is not intended to expand the scope of the category of clinical trials,” subsequent implementation has done just that.  An August 2017 statement by Michael Lauer, deputy director for extramural research at NIH, and a set of case studies demonstrate that most basic research studies with humans would be considered to be clinical trials.  (Some previous notices, including NOT-OD-16-147 and NOT-OD-16-149, were unclear about whether basic research would be included.)

The stated goal of the NIH leadership is to increase the transparency of funded research and to ensure the reporting of results of all studies.  Achieving such goals, they note, can help address the replicability challenge as well as honor the contributions of research participants.  The leadership also appears to be responding to concerns about the management of clinical trials that have arisen in Congress and in a 2016 Government Accountability Office report

Although many scientists and scientific organizations support enhanced transparency and reporting for all forms of research, they do not view the incorporation of basic research into a clinical trials framework as an appropriate or useful way to achieve that goal.  Other mechanisms, such as the Open Science Framework, can be used to ensure the transparency of basic studies.

Scientists respond

A petition asking NIH to delay implementation of the policy (which is set to go into effect for 2018 application deadlines) has drawn more than 3400 endorsements, including from the American Psychological Association (APA). 

Representatives of a variety of scientific and academic organizations, including APA and its partners in the Federation of Associations in Behavioral and Brain Sciences, have also written to and spoken with NIH leaders to express opposition to the policy.  These organizations are now collaborating more closely among themselves and with individual scientists in order to speak with a unified voice to NIH.  The aim is to reverse or at least delay the expansion of the “clinical trial” definition and to help NIH develop a more constructive approach to enhancing transparency of basic research.   

For further developments on this issue, follow Psychological Science Agenda, APA Science Advocacy Blog and @APAScience on Twitter.  You may share comments and questions with Pat Kobor in the Science Directorate of the American Psychological Association.