Copyright 2014 American Medical Association. All rights reserved. Reanalyses of Randomized Clinical Trial Data

W hether trial investigators should be required tomake patient data from randomized clinical trials(RCTs) available for reanalysis is controversial.1-5 Since reanalyses of raw data from oseltamivir trials led to conclusions different from those in the original trials and subsequent meta-analyses, some authors have argued that a standard of data sharing and reanalysis should be more widely adopted and could have major consequences for individual and public health, and that paying consumers (the public) should have access to complete information about drugs and devices.6 Arguments against accessibility to raw data and reanaly-ses include potential risk to trial patient confidentiality7; inappropriate dredging of data sets, resulting in spurious findings6; release of commercially sensitive information6; the requirement for a data infrastructure for sharing data and reanalysis8; and “rogue ” reanalysis by nonexperts or b