Clinical Trial Data

Underlying clinical trial data are the detailed data generated in a trial rather than only the summarized journal publication. Peer review is incomplete when reviewers and editors cannot examine the underlying clinical trial data. The article treats reliance on sponsor-controlled summaries as a departure from open scientific norms. Errors or manipulations can remain hidden when reviewers only see published articles instead of full underlying data. Litigation can reveal company documents, trial data, and internal analyses that physicians and journal reviewers normally cannot see.