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|NIH Considering New Definition of 'Clinical Trial'|
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:
The broader issue is described here:
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 (email@example.com). 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).
June 2, 2017
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:
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.
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:
Please let me know if I can provide any further information, and thank you in advance for your help.