Limping Toward the Goal Posts: Basic Science and Clinical Trials at NIH

Paula Skedsvold and Jeremy Wolfe*

In the summer of 2017, researchers in the mind, brain, and behavioral science communities became engaged in a dialogue of sorts with the National Institutes of Health about their plan to reclassify a great deal of basic science research as “clinical trials” and, as a result, subject that research to a number of policies specific to clinical trials. Our conversation with NIH has progressed, but it is not finished.

Progress

To be sure, there has been progress. Through interactions with NIH staff, the case studies that define whether a research project is or is not a clinical trial have been revised on multiple occasions, resulting in an apparent narrowing of the reach of the clinical trial definition to include less basic behavioral and brain science. The latest revision of the case studies can be found here.

Case 18 (in its many parts) has been central to the definition of clinical trials from the vantage point of basic behavioral and brain science. That case is revised in the newest list and it seems that much of our basic science (behavioral and fMRI) has been removed from the clinical trials framework. Cases 24 and 26 have also been of concern to our science community. In the latest revision, these case studies have been removed. It is unclear at this time whether the case studies are undergoing revision and will be posted later.

Beyond the case studies, there is other progress to report. Basic scientists have been concerned about a variety of issues including the implications of the new policies for grant application and review and for training from undergraduate to postdoctoral levels. To get a better understanding about progress made in these areas, FABBS immediate Past-President Jeremy Wolfe posed a series of questions to NIH’s Deputy Director for Extramural Research, Michael Lauer. These questions and NIH’s answers were just published in Nature Human Behavior.

In addition, NIH is signaling that the agency is prepared to troubleshoot new issues related to implementation of the clinical trials policies as they arise. We are interacting with the agency about the best ways to collect and convey this information.

Getting to the Core Issue(s)

As we understand it, NIH’s goals in taking these actions were to address problems identified by the Government Accountability Office in collecting information about the clinical trials it funded. In addition, there were concerns that the results of clinical trials were not being published in a timely manner.

As FABBS and other organizations have conveyed to NIH, there are alternative vehicles for registering studies and reporting findings that are better tailored for basic science. For those basic science studies that are still deemed to be clinical trials, other systems such as the Open Science Framework may be a user-friendly alternative. Since last summer, there has been movement in this direction as well. NIH is currently in discussions with Open Science Framework Director Brian Nosek about the possibility that basic scientists might register and report through OSF rather than clinicaltrials.gov, if they so choose. Doing so would reduce the number of irrelevant fields for basic scientists and, hopefully, make the process easier. According to Nosek, OSF and NIH are working through technical and implementation details so that, if an investigator used OSF, it would be as efficient and effective a process as possible. Since NIH needs a public database to house the information, data elements from OSF would be pulled into clinicaltrials.gov.

A Path Forward

Most basic scientists would like to maintain the historical distinction between basic science and clinical trials. The community is not opposed to the goals of openness and accountability. However, the path to those goals does not require a fundamental change in the meaning of the term “clinical trial.” Although there is progress with NIH, it is unclear where this will land, but we will continue to interact with agency staff to get this right. As long as the policies affect basic brain and behavioral science, we will be at the table trying to make them work for our scientists. We will also continue to share information with organizations such as the Council on Governmental Relations, which has taken a leadership role on this issue for higher education organizations.

FABBS is also engaged in conversations with key staff on Capitol Hill about the continued concerns of the community, and Congressional staff are in communication with NIH. These conversations will also continue. While it is not an easy process for anyone involved, we are hopeful that we will continue to make progress one way or another.


*Paula Skedsvold, JD PhD, is Executive Director of the Federation of Associations in Behavioral and Brain Sciences (FABBS).

 

 

 

 

*Jeremy Wolfe, PhD, is immediate Past-President of FABBS and Professor at Brigham & Women’s Hospital and Harvard Medical School.

6 thoughts on “Limping Toward the Goal Posts: Basic Science and Clinical Trials at NIH

  1. Thanks for all the great work- real progress! This may be obvious, but case 18 still seems very ambiguous to me unless I am missing something. Suppose I want to better understand the neural representations involved in reading. I measure neural activity with fMRI while subjects are in multiple conditions in a non-standard task (i.e. a task my lab has come up with to probe details of the neural representations used for reading). There is no clear sub-case of case 18 that maps onto this as far as I can tell. One could say that reading has implications for health and that the different conditions constitute an intervention and so this should be a clinical trial. But it also seems to be very representative of much basic research. Are studies like this the subject of ongoing negotiation? Thanks again.

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    1. I think you have identified one of the ongoing concerns. A good bit of research will fall outside or between the case studies. Regarding the case studies in 18, I have asked two scientists who weighed in with NIH during the revision of those particular case studies if they will weigh in here. Perhaps they have additional insights based on their conversations? In the interim, we have been told by NIH that it’s best to ask your program officer. Mike Lauer, NIH’s Deputy Director for Extramural Research, has also said that he would be happy to help investigators and would field these questions. His email address is: michael.lauer@nih.gov. Finally, NIH has assured us that they are being more flexible during this round since there are still a number of questions. Of course, there is the concern that if your research is not a clinical trial this time (perhaps due to flexibility), can you count on that the next time around? As you can see, this is an evolving process, but we’ll keep working on it until the issues for our scientists are resolved. We will also share your particular question with NIH staff. Good luck!

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  2. Here is a timeline of developments in this matter:

    • October 2014 – NIH publishes revised definition of “Clinical Trial”. Excerpt: “The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials. IT IS NOT INTENDED TO EXPAND THE SCOPE OF THE CATEGORY OF CLINICAL TRIALS.” (emphasis added) [1]

    • August 2017 – Dr. Michael Lauer asserts that all fMRI studies in humans shall be classified as clinical trials. [2]

    • September 2017 – Dr. Lauer withdraws his assertion that all fMRI studies in humans are to be classified as clinical trials. [3]

    • September 2017 – Dr. Lauer asserts that “…three years ago the definition of what is considered to be a clinical trial was expanded.” [4]

    • 8 January 2018 – Dr. Lauer asserts that some fMRI studies (including those involving ‘wins’ and ‘losses’ in a ‘gambling task’) in humans shall automatically be classified as clinical trials. [5]

    • 17 January 2018 – Dr. Lauer withdraws his assertion that some fMRI studies in humans are to be automatically classified as clinical trials. [6]

    _____
    1. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
    2. https://web.archive.org/web/20170831200751/https:/grants.nih.gov/policy/clinical-trials/case-studies.htm – see Case 18.
    3. https://web.archive.org/web/20171006013235/https://grants.nih.gov/policy/clinical-trials/case-studies.htm – see Cases 18a & 18b.
    4. https://www.csr.nih.gov/CSRPRP/2017/09/interview-with-dr-mike-lauer-director-nih-office-of-extramural-research/
    5. https://web.archive.org/web/20180111205025/https://grants.nih.gov/policy/clinical-trials/case-studies.htm – see Case 18c.
    6. https://grants.nih.gov/policy/clinical-trials/case-studies.htm – Accessed 17 January 2018.

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