Research misconduct and data fraud in clinical trials: prevalence and causal factors.

The disclosure of cases of research misconduct in clinical trials, conventionally defined as fabrication, falsification or plagiarism, has been a disturbingly common phenomenon in recent years. Such cases can potentially harm patients enrolled on the trials in question or patients treated based on the results of those trials and can seriously undermine the scientific and public trust in the validity of clinical trial results. Here, I review what is known about the prevalence of research misconduct in general and the contributing or causal factors leading to the misconduct. The evidence on prevalence is unreliable and fraught with definitional problems and with study design issues. Nevertheless, the evidence taken as a whole seems to suggest that cases of the most serious types of misconduct, fabrication and falsification (i.e., data fraud), are relatively rare but that other types of questionable research practices are quite common. There have been many individual, institutional and scientific factors proposed for misconduct but, as is the case with estimates of prevalence, reliable empirical evidence on the strength and relative importance of these factors is lacking. However, it seems clear that the view of misconduct as being simply the result of aberrant or self-delusional personalities likely underestimates the effect of other important factors and inhibits the development of effective prevention strategies.

Duke Scholars

Author Stephen L. George Biostatistics & Bioinformatics, Division of Biostatistics