title: Disclosure of clinical trial results when product development is abandoned.
abstract: Currently, sponsors are not required to report the outcomes of clinical research on drugs or devices that do not lead to an approved product. Consequently, the public cannot benefit from scientific information derived from all failed or abandoned drugs and devices. Provisions in the U.S. Food and Drug Administration Amendments Act of 2007 provide an opportunity for the Department of Health and Human Services to rectify this situation. By reporting the results of clinical trials of abandoned products in a publicly accessible database and in the peer-reviewed journal literature, sponsors would satisfy a core ethical obligation of clinical research and enhance translational science.
authors.affiliation: Department of Neurology, School of Medicine, University of California, Davis, Sacramento, CA 95817, USA. rogawski@ucdavis.edu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Rogawski
authors.forename: Howard J
authors.initials: HJ
authors.lastname: Federoff
mesh_terms: D002986:Clinical Trials as Topic; D030881:Disclosure; D017277:Drug Approval; D006801:Humans; D010506:Periodicals as Topic; D017594:Publication Bias; D017211:Treatment Failure