Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that investigators report summary results of eligible clinical trials to ClinicalTrials.gov within 1 year of trial completion. This requirement is in part intended to promote medical innovation by enabling meta-analyses and further research based on the results of clinical trials.1 Sharing trial results helps to counteract a publication bias favoring positive trials that can “distort the evidence base” of clinical guidelines and patient care.2 In addition, sharing the results of clinical trials is important for ethical reasons: it helps to justify exposing participants to the risks of clinical trials and shows respect for those who assume these risks.
Doernberg SN, Wendler D. Ensuring Respect for Human Research ParticipantsInstitutional Review Boards and Sharing Results From Research. JAMA. 2016;316(11):1149-1150. doi:10.1001/jama.2016.7970