Clinical Trials: FDA proposes new Data Falsification Rule

The US Food and Drug Administration (FDA) proposed an updated regulation to require sponsors to report information pertaining to any individual that has or may have engaged in falsification of data in clinical trial studies involving human or animal subjects (Federal Register). A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information.

The FDA states that the proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labelling claims and to protect research subjects.

Because of the fact that a sponsor could face criminal sanctions if he fails to submit this information on time, the proposed rule raised some concerns in the pharmaceutical industry. The Pharmaceutical Research and Manufacturers of America (PhRMA) for example fears that "the broad scope of the rule would likely result in sponsors reporting unconfirmed falsifications as well as inadvertent errors. These reports would therefore include allegations against investigators who have committed no wrongdoing" and that "investigators who feel as though they have been falsely accused of engaging in research misconduct or have suffered damage to their professional reputation on account of the report". The PhRMA proposes that "these problems could be mitigated at least somewhat if the proposed rule were limited to reporting only upon completion of an investigation by the sponsor".

Source: PhRMA comment on proposed rule: Reporting Information Regarding Falsification of Data.

However fraud and falsification of study data are unfortunately not uncommon and can:

  • Place all trial subjects at possible safety risk.
  • Jeopardize reliability of submitted or published data.
  • Compromise overall patient safety by having a product on the market which had been licensed on the basis of false data.

So a small number of investigators can have a broad impact on many applications. As this is a serious problem, the ECA will discuss incidences and impact of misconduct and fraud in Clinical Research and the potential indicators at the ECA Conference on GMP meets GCP, 10 - 12  November 2010, Berlin, Germany.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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