Why Is ClinicalTrials.gov Still Struggling? | The Scholarly Kitchen

"ClinicalTrials.gov was launched as a voluntary registry in the 1990s, but the stakes were raised after a number of scandals, leading to the Food and Drug Administration Amendments Act (FDAAA), which in 2005 mandated that clinical trials be registered. With the passage of this act, clinical researchers in the US were required to register trials and deposit trial information at ClinicalTrials.gov, for all the right reasons – transparency, responsibility, and public benefit. The mandate garnered support from hundreds of journal editors who pledged to only publish research findings registered in the system. In the context of drug trial scandals, mounting retractions, and funding concerns, the goal of a more transparent source of scientific accountability was widely lauded. Ever since, there have been basic problems, including observed delays in the registration of trials, which some worry may allow for hypotheses to be revised based on preliminary data. This would undermine the database’s spirit and goals, as it was established partially to reduce the ability to modify research hypotheses to match post-hoc findings — something which may be happening. In 2015, a paper in PLOS ONE found that of 137 randomized controlled trials published in the major medical journals (Lancet, JAMA, NEJM, BMJ, and Annals), 15% had the primary outcome changed when compared to the initial trial registration, while pre-specified non-primary outcomes were omitted in 39% and new non-primary outcomes were introduced in 44% ..."