Dear Colleagues

The NIH is considering a new definition of clinical trials that would wrongly classify the work that many of us do as clinical trials.

The definition is found here:
http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20Clinical%20Trial%2010-23-2014-UPDATED_0.pdf

The broader issue is described here:
http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials

This new rule has many adverse consequences for NIH, for you as a researcher, and for the public and their access to ‘real’ clinical trials. Bill Riley, Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR), is working to modify this definition. We urge you to send an email to Bill (william.riley@nih.gov). He is collecting information over the next few days. We provide two models below. As you will see, these lay out the problems that come with this new definition. Your most important contribution will be a specific example from your own work. Please modify one of these letters or write your own describing the work you do and how it would fit the new NIH definition of clinical trials. This is a time-urgent issue as Bill plans to speak to Francis Collins in the next few days.

Please disseminate widely (e.g. post to your mailing lists, Facebook page).

Thanks,
Jeremy Wolfe & Nancy Kanwisher

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June 2, 2017

William Riley
NIH OBSSR
william.riley@nih.gov

Dear Bill,

I am writing to express my concern about the NIH Definition of Clinical Trial. It seems likely to classify a large body of research as ‘clinical trials’ that should not be so classified. Let me give you an example from my own work. I am interested in the problem of “incidental finding errors” in radiology. When radiologists examine an image for one specific problem (e.g. pneumonia), they also search for other clinically significant findings (e.g. signs of lung cancer). Unfortunately, these “incidental findings” are missed at relatively high rates. Radiologists are an expensive and limited resource as experimental observers, so we have developed a “hybrid search” analog of the incidental finding problem that can be used with non-experts. In hybrid search, observers look for an instance of any several candidate targets held in memory. Our observers search for any of three specific (e.g. this picture of this hat) and three categorical (e.g. any animal) targets. Specific targets are the analog of the radiologist’s primary task. Categorical targets are the analog of incidental findings. I will spare you the details but I am happy to say this is a good ‘model system’ for the problem we are trying to understand. It is not a clinical trial in any meaningful sense of the word but it would be classified as a clinical trial under the new definition. It involves “a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes”, especially if “behavioral process” is defined as “positive or negative changes to psychological … parameters”. In this case, we are making manipulations that alter error rates.

It seems obvious that this work should not be classified as a ‘clinical trial’ and this is just one of a huge body of research in cognitive and sensory science that would be reclassified. This reclassification has many negative consequences:

1. By posting such clinical trials on government websites, we will confuse the public about the nature of the clinical trials.
2. We will make it less likely that members of the public will be able to find and enroll in true clinical trials.
3. Because the public will not appreciate the subtleties of the new definition of ‘clinical trial’, this will hold the researchers and the NIH up to public ridicule for claiming to be doing ‘clinical trials’ of matters that are clearly not clinical issues (e.g. error rates in hybrid search tasks).
4. It will dilute NIH oversight of real clinical trials that should be monitored.
5. It will add to the bureaucratic burden for researchers and their institutions.
6. This is likely to be particularly true for researchers at smaller schools.
7. An undergraduate doing an honors thesis or a graduate student doing something as simple as a first-year project would have to register with clinicaltrials.gov.
8. Grant review will be significantly disrupted by the requirement that “clinical trial” grants must be reviewed by study sections that review “clinical trials”.

I would be happy to elaborate on any of these points, but let me conclude by noting that this policy seems to be in strong contradiction with the streamlining of the research process proposed in the revised Common Rule.

I strongly urge you to support a more sensible definition of “clinical trial” at the NIH.

Thank you for your work on this topic to date.

Sincerely,
Jeremy Wolfe

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Dear Bill,

I greatly appreciate your informing us yesterday about the proposed new NIH definition of “clinical trial”: (http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials).

I am writing to share my concern that broadening the definition in this fashion will likely have many negative consequences listed below. But I’ll be concrete by first describing one (of many) examples of studies from my own current research, which as far as I can tell would be classified as a clinical trial, to the detriment of many. I am currently running an fMRI experiment on normal adults characterizing a region of the brain that responds to both human faces and human voices (compared to numerous other stimulus conditions). To understand this brain region and its role in social cognition (and perhaps autism) we are measuring its response to many different stimulus types. So, we scan many typical adults (sometimes assigned to different groups), we show them different kinds of visual and auditory stimuli (an intervention) while we measure the magnitude of the fMRI response of this region to these stimuli (a “health-related biomedical or behavioral outcome”). Thus this experiment (and many others like it in my lab) would fit the proposed new definition of a clinical trial, even though it is in fact nothing of the kind.

The negative consequences of this new definition include:

1. I would be required to register my study as a clinical trial, which would seriously mislead members of the public who may be looking for an actual clinical trial, wasting their time and causing confusion.
2. It would dilute the resources NIH has available for oversight of real trials that actually should be monitored as such.
3. Because the public will not appreciate the subtleties of the new definition of ‘clinical trial’, this will hold the field and the NIH up to public ridicule for claiming to be doing ‘clinical trials’ of matters that are clearly not clinical issues.
4. The new definition will drastically increase the bureaucratic burden to PIs and universities, and disproportionately harm researchers at smaller schools who have smaller bureaucratic infrastructures.
5. An undergraduate doing an honors thesis or a graduate student doing something as simple as a first-year project would have to register the relevant research and do battle with clinicaltrials.gov -- so we run the risk of massive red tape on very simple and innocuous projects. It would serve as a serious barrier to mentoring very early stage investigators on anything involving randomization.

Please let me know if I can provide any further information, and thank you in advance for your help.

Nancy Kanwisher
MIT