NIH is asked to rethink clinical trials policy

Delaying Definition

NIH is asked to rethink clinical trials policy

Large numbers of medical researchers, who normally form an important part of the National Institutes of Health (NIH) constituency, have joined in a worried open letter to the agency, calling on NIH to hold off on revising its definition of a clinical trial. Many researchers believe that the proposed new policy would have severe “unintended consequences.”

Jim Pekar, writing on the website, reports that in addition to the open letter, a second joint letter, written by academic groups, has been released as well and expresses the same concerns. The open letter calls on the NIH to “invite representatives from affected basic research communities, listen to the concerns raised and work with us to shape a policy for this important segment of NIH grantees,” while the joint letter asks “to assist the NIH in reaching the laudable goals of transparency and accountability, consistent with principles.” One researcher, writing in the journal Neuron called the new policy “dangerously chilling to basic science if implemented as literally written.”

The NIH wants to expand the definition of a clinical trial to include the underlying research that preceded it, and then revise and regulate accordingly. While the agency has said previously that a new definition of what constitutes a clinical trial “is not intended to expand the scope of the category of clinical trials,” the new policy, expected to take effect in January 2018, would in fact do so by redefining activities that many professionals see as basic research into the definition of “clinical trial.”

Once a project is registered with, strict accountability takes over. This could mean that paperwork and non-science efforts will increase proportionately with the broader definition and will harm research and the advancement of healthcare. The NIH has actually said that it wants to “exert more control.”

Clinical trials are highly structured and must be mathematically meaningful. There is little room for creativity. By contrast, fundamental research often depends on fluid thinking and changes of direction. For the NIH to classify this as part of a clinical trial alarms many researchers.

Keeping the current definition of a clinical trial is widely seen as important for preserving the integrity of clinical trials and advancing the cause of curing disease. One compromise being discussed by researchers involves creating a second official website in addition to on which all information relating to a clinical trial, including that which scientists consider extraneous, would be displayed. That site could include synopses of other NIH research and links to other data.

Pekar concludes, “Basic research and clinical trials both serve public health, and respecting the distinction between the two is valuable. The NIH should slow down and take time to fulfill the good intentions and laudable goal of increasing transparency and reporting in clinical research, without the harm to science, health and trust that the unintended consequences of the new policies will bring.”