March 26, 2020
In response to a request for comment, FABBS provided feedback on NIH plans regarding the modernization of ClinicalTrials.gov. FABBS strongly supports efforts to update infrastructure and usability of ClinicalTrials.gov and shares a strong commitment to transparency and maximizing availability of federally funded research. FABBS identified concerns about consequences of the NIH expansion of the definition of clinical trials, particularly with regards to the challenges of registering Basic Experimental Studies involving Humans (BESH) on ClinicalTrials.gov.
FABBS comments focused on website functionality and identifying four characteristics of BESH studies that make registration unworkable in current ClinicalTrials.gov website.
- Multiple, short-term experiments – BESH studies are often small, short studies. Unlike a trial that lasts for a year or more, BESH experiments may be completed within weeks. Reporting BESH in a database like ClinicalTrials.gov imposes the paperwork burden of a drug safety trial, a considerable administrative burden that is incommensurate with the minimal associated risks.
- Few participants – BESH studies generally have relatively few observers/participants, significantly reducing usefulness of extensive discussion of the patient population as is currently required on ClinicalTrials.gov.
- Iterative process – BESH research is can be iterative in nature, evolving with new information. Often times as the work progresses, specific experiments originally outlined in a grant proposal are massively modified or are never conducted. In BESH, this is not evidence of a failed clinical trial. More typically, it is evidence of good BESH science, with the next experiment informed by results of the last experiment. However, current ClinicalTrials.gov registration does not allow for this flexibility. Even if it were possible to anticipate all of the potential directions research could go, it could jeopardize the science and be enormously time consuming and of no value.
- Capturing results – FABBS supports the idea of having a brief record of experiment outcomes, even for experiments that seemed interesting at the time but produced no relevant, publishable results. Typically, uninteresting BESH studies do not get published. Accordingly, it would be inaccurate to presume that the failure to publish indicates scientific misbehavior. More useful records of BESH would be, for example, the fate of a data set.
NIH has released a Notice of Special Interest for competitive revisions to support the expansion of existing programs to include research on firearm injury and mortality prevention. Back in December, as part of the federal budget for fiscal year 2020, Congress approved $25 million to be used for gun violence research — $12.5 each to the Center for Disease Control and NIH — after the Dickey Amendment prevented such funding for over 20 years. The Office of Behavioral and Social Sciences Research is leading this NIH-wide effort.
