[visionlist] Help us Oppose NIH's Proposed New Definition of "Clinical Trial"

George Sperling sperling at uci.edu
Sun Jun 4 14:34:15 -05 2017

Re Gary Rubin 's comment that I interpret to mean that perhaps we all hope to do 
work that ultimately may have a “health-related biomedical or behavioral 
outcome” on " biomedical or behavioral status or quality of life”?

  If one takes the broadest point of view, consider the following studies that 
can have profound effect on both individual and on societal health-related 
outcomes:  Different interventions that affect voting patterns--whether people 
will vote for or against inclusive governmental health insurance, studies on 
educational interventions that may affect how people can discriminate between 
and respond to real and false news concerning climate change and air pollution, 
and agricultural studies with farmers assigned to groups that continue using 
their habitual fertilizers and pesticides versus farmers that are induced not 
to.  All can have very important implications on "biomedical or behavioral 
status or quality of life" of the individuals in the studies as well as on the 
public.  These studies do not fall under the category of clinical trials as they 
are conventionally understood but might under a broad interpretation of the 
above NIH definition of Clinical Trial.  While one may believe that all such 
studies as well as those suggested by other writers require governmental 
oversight, the NIH rules for clinical trials are not the appropriate guidelines 
for these sorts of studies and therefore should be reformulated to exclude 
them.  The NIH definitions are a legalistic matter in sense that what ultimately 
is important is not what the rules intend but what the rules actually say.  I 
suggest that the most interested parties coordinate to consult with lawyers and 
other experts on how to best reformulate and clarify NIH rules as well as to 
incorporate specific exclusions, and then send very specific suggestions to NIH.

George Sperling, University of California, Irvine, Department of Cognitive Sciences


On 6/4/17 4:23 AM, Rubin, Gary wrote:
> Can you argue that the results of your studies do not conform to the 
> definition of a “health-related biomedical or behavioral outcome” in that they 
> don’t have an effect on " biomedical or behavioral status or quality of life”?
> Gary Rubin
> UCL Institute of Ophthalmology (London)
>> On 2 Jun 2017, at 19:19, Nancy Kanwisher <ngk at mit.edu <mailto:ngk at mit.edu>> 
>> wrote:
>> 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, is 
>> working to modify this definition. We urge you to send an email to Bill. 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
>> ================================
>> June 2, 2017
>> William Riley
>> william.riley at nih.gov <mailto:william.riley at 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 <http://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
>> ==========================
>> 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 
>> <http://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
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