Influence of Clinical Research Investigator Fraud on Clinical Trial Participation.

The number of clinical research investigators that the US Food and Drug Administration has disqualified or totally restricted has been increasing since 1964. In addition, several public polls and surveys indicate a major dilemma in clinical trial participation and public perceptions of clinical research. This study investigates how clinical investigator fraud or misconduct influences public perceptions of participation in clinical trials. An electronic survey was developed for the faculty of Eastern Michigan University. The survey results (11.2% response rate) indicated that 81% of respondents were willing to consider participation in a clinical trial or had participated. However, when the respondents were told of a case of investigator fraud, approximately 25% of willing respondents were now discouraged from participation. The influence of the knowledge of investigator fraud did not seem to be greatly correlated with the geographic location of the event relative to the location of the respondents. While it seems that news of investigator fraud would therefore significantly affect enrollment efforts in ongoing clinical studies, these results reflect only a select group of highly educated people, and more definitive studies are recommended to understand the impact of investigator fraud and the duration of this impact on patient recruitment into clinical studies.