What Are the Consequences of Fabricating Clinical Trial Data?

From time to time we hear about situations where investigators are involved with the fabrication of clinical trial data.  Not only is this unethical because culprits are potentially putting peoples lives at risk, but it is against the law.  We wanted to share our first hand experience with an investigator in a situation like this and the respective consequences of such actions. 

The Background

We had a study with twenty investigative sites underway in seasonal allergic rhinitis clinical trials.  For each investigative site, we had prior trial experience and we were confident they could perform well since each site was monitored on a regular basis.

As expected, the study was completed on time and the analysis showed efficacy and acceptable safety results.  Not long after this but prior to submitting the report of clinical findings to the FDA, we received a telephone call from the clinical coordinator at one of the sites.  The coordinator expressed that the study had not been conducted in accordance with the protocol and Good Clinical Practices at his site.

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The Situation

The Principle Investigator had not been present for two weeks out of the six-week trial period because he was on vacation with his family.  Unfortunately, he did not have an associate investigator and told his coordinator to make the investigator judgments for efficacy symptom scores in his place.  When he returned from his vacation and reviewed the scores by the coordinator, the investigator thought they were incorrect even though the study was a double-blind design.  The investigator not only changed the scores but went to a local printing shop and had our study reports duplicated and submitted to us as the original reports.

With this information, an analysis with and without the data from this site was performed.  The results still demonstrated efficacy and safety. This breech was reported to the FDA and an investigation was conducted by the FDA and the cheating was confirmed.

 

The Consequence

The investigator was subjected to criminal charges.  The end result was that he lost his investigative site business and he signed a court ordered consent decree to never be involved in any future investigative studies.  Most detrimental, this investigator was placed on the FDA black-listed investigator’s list, which is publicly known.  We don't know if his situation was made public in local news outlets nor do we know how it may have affected his practice or his state license but it certainly had a devastating effect on him and his family.

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