ACTION ALERT: Register Your Concerns About the Problematic NIH “Clinical Trials” Definition

October 17, 2018

As COSSA has been reporting, the National Institutes of Health (NIH) has been taking steps in recent years to enhance its stewardship of and increase transparency over the clinical trials it funds. This has included the development of a new, expanded definition of the term “clinical trial.” According to the NIH definition (released in 2014), a “clinical trial” is:

“A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

In other words, research that involves a prospective experimental manipulation of an independent variable would fall under the definition of a clinical trial and trigger the need for researchers to adhere to a number of new registering and reporting requirements using clinicaltrials.gov. Many basic behavioral and social science studies will be caught up in these new requirements.

COSSA and countless other advocates have been working for more than a year to convince NIH to reconsider the definitional change and develop registration and reporting procedures—separate from clinicaltrials.gov—that are more suitable for basic research studies involving human subjects. Although some marginal changes have been made in response to community pressure, we still have major concerns.

We need your help!

The latest development is the release of a Request for Information (RFI) seeking public input specifically on registering and reporting of basic science studies involving human participants. Comments are due by November 12.

However, COSSA’s concerns go well-beyond the issues of registration and reporting of research findings. We fundamentally object to the revised “clinical trials” definition and the impacts it can have on recasting basic science studies as clinical trials going forward.

Therefore, we are asking for your assistance in responding to the RFI to register your concern about the expanded definition. Scroll down for step-by-step guidance as well as sample language you can use in submitting your comments. Note that responses can only be submitted using an online form that limits entries into the comment boxes to 500 words.

Thank you in advance for taking action on this important issue. Should you require additional information, background, or guidance, do not hesitate to contact the COSSA team. You can also find additional information in COSSA’s coverage of the issue.

Remember, November 12 is the deadline for comments. Spread the word!


4 EASY STEPS TO ACTION

STEP 1: Go to the RFI response form HERE.

STEP 2: Provide responses to any of the five topics included on the form, but especially the fifth topic.

Four of the topics for which NIH is seeking input are specific to clinicaltrials.gov and other platforms and processes for registering and reporting research findings. Given that COSSA’s concerns are much broader than issues of registering and reporting on clinicaltrials.gov, we urge you to use the below sample text in your response to the LAST question:

“Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.” 

COSSA’s goal is it get as many researchers working in basic science as possible to weigh in on our collective concerns surrounding the clinical trials definition. Of course, if you have responses to any of the other four questions, feel free to include them as well.

SAMPLE RESPONSE

You are welcome to use any/all of the points below in your response to the fifth question on the RFI response form. (Note: There is a 500-word limit per comment box. The sample response below is 430 words. Feel free to tailor the entry, just be cognizant of the word limit.)

I remain concerned about NIH’s broadened definition of “clinical trials” and its impact on fundamental research in [name your field or research area]. The move to redefine some basic research studies in this way will have unforeseen consequences that reach beyond the NIH grantee community.

One such concern is with public access to timely and accurate clinical trials information through clinicaltrials.gov. It would be a public disservice to muddy clinicaltrials.gov with research findings resulting from basic science studies that were not designed or intended to yield results affecting potential interventions. Other impacts could include confusion in the IRB process, inconsistency with institutional (i.e. university) policies, or challenges to international collaborations.

NIH is the world leader in biomedical and behavioral research. In achieving this status, it has invested in a broad range of research activities, from basic discovery that relies on hypothesis testing and innovative new ideas, to clinical trials that play the critical role of arbiter for ensuring safety and efficacy of new treatments and interventions. These activities are equally important components of the U.S. biomedical research enterprise. They also serve distinct (albeit connected) purposes and deserve infrastructure that allow both to flourish.

Given these concerns, I echo many of my colleagues in asking NIH to revisit the definition of a “clinical trial.” Specifically, I urge you to:

(1) Clarify the definition of an “intervention.”
The current definition of an “intervention” is exceptionally broad and can be interpreted as including any prospective manipulation of a subject’s environment. A suggested change that could further clarify the definition of “clinical trials” might be: “an intervention that has the intent to change the health status of the individual/human subject.” Such a change would distinguish studies according to the intent of the research or trial, not according to whether subjects are prospectively assigned, regardless of intent relative to health outcome.

(2) Eliminate the new class of basic research called, “prospective basic science studies involving human participants.”
Creating a third category of research between basic and clinical will cause confusion among the research community, not to mention similar downstream impacts noted earlier. In its place, a system should be developed—in consultation with the basic research community—that more appropriately allows for the registering and reporting of all basic science studies involving human participants while not classifying them as clinical trials. I do not agree with NIH’s position that certain areas of research meet the definitions of both “basic research” and “clinical research,” primarily because the intent of basic research studies are not to test an intervention or treatment.

Thank you for considering these recommendations.

STEP 3: Let COSSA know that you have responded to the RFI with a quick email so we can gauge the response from the behavioral and social science community. If you receive a response from NIH, share that with us as well.

STEP 4: Share this alert! Share this link with your colleagues and encourage them to weigh in as well. Remember, comments are due by November 12.

THANK YOU!