Data fraud in clinical trials.

TitleData fraud in clinical trials.
Publication TypeJournal Article
Year of Publication2015
AuthorsGeorge, Stephen L., and Marc Buyse
JournalClin Investig (Lond)
Date Published2015

Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality.

Alternate JournalClin Investig (Lond)
Original PublicationData fraud in clinical trials.
PubMed ID25729561
PubMed Central IDPMC4340084
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States