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.