Wednesday, March 6, 2013

Perverse incentives in clinical trials

Does this sound familiar?

"Because of the enormous financial risks associated with clinical trials, pharmaceutical companies take great pains to ensure that their drugs reach the market.. And while it is unlikely that a sponsor would directly instruct a clinical investigator to generate fraudulent data, investigators are incentivized to do whatever is necessary to generate positive results. Money appears to be the primary motive for clinical investigator fraud. The major issue is how clinical investigators are paid, which is typically based on the number of patients enrolled in a study and the length of time these patients are retained. Also, if a patient drops out of a study early, the investigator usually only gets paid a portion of the full amount. Thus, in order to maximize their paycheck, clinical investigators may invent fictional patients, purposely enroll ineligible participants, and falsify medical assessments to prevent patients from withdrawing from a study. Additionally, investigators may purposely omit adverse events in order to ensure the study continues until its conclusion and is not cancelled early due to safety issues. A successful clinical investigation will not only result in a larger paycheck, but will also result in a higher likelihood of being hired for future clinical investigations as the investigator builds a reputation for getting clinical trials done."

See "FDA Enforcement of Criminal Liability for Clinical Investigator Fraud" by  Vandya Swaminathan and Matthew Avery in the Hastings Science and Technology Law Journal.

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