Data fraud in clinical trials.
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.
Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC 27705-3833, USA.
Stephen L
SL
George
IDDI (International Drug Development Institute) Inc., San Francisco, CA 94109, USA.
Marc
M
Buyse
central statistical monitoring; data fabrication and falsification; data fraud; data quality