2019 AER Conference
Clinical trials are conducted and subjects are recruited in the name of advancing science. However, a growing body of research suggests that many initiated trials have little or no chance of providing valuable information (e.g., trials that address a question that has already been answered; trials that address a trivial question that is of no scientific or clinical import; trials that have design flaws that predictably would block them from producing a valid answer; trials that are very unlikely to complete as planned because of lack of subject recruitment). More broadly, human experimentation that has little to no prospect of generating valuable knowledge violates basic ethical principles and can cause considerable harm. First, participants may be burdened by the demands of study enrolment, while mistakenly believing that they are contributing to medical progress. Second, trials lacking social value divert participants, researchers, and other resources from other endeavors, including more valuable trials. Third, valueless trials degrade the evidence used in research, care and policy. Academic medical centers and IRBs frequently serve as the main gatekeeper to the initiation of new studies, and thus must do what they can to ensure that the promise of scientific advancement is reasonably likely to be achieved. This panel will address the role academic institutions and IRBs can play in identifying and reducing the initiation and continuation of low value trials by (a) understanding key principles underlying potential value of a trial; (b) ensuring a landscape analysis has been conducted to enable consideration of the scientific context in which the research will occur; and (c) ensuring the trial will be registered and reported in accordance with current legal and other policies.