Saturday, February 28, 2009

Liability and Indemnification of data monitoring committee members

As stated in Demets' paper "Liability issues for data monitoring committee members" (Clinical
Trials 2004; 1: 525–531): In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study participants. Because DMCs
bear serious responsibility for participant safety, their members may be legally liable
for their actions.

With increasing DMC monitoring in clinical trials, the liability and indemnification issues are the topic of the recent data monitoring committee conference. In the situation where a study was terminated based on DMC's suggestion, the study participants could file lawsuit on either the DMC members or the sponsor for not doing the diligent work to stop the trial or stop the trial sooner enough. For example, Pfizer was sued for its Torcetrapib trial even though Pfizer is cleared of any wrongdoing. Recent events (eg Cox-IIs, Vioxx) have raised the potential for litigation and DMC members have been gotten a subpoena. For protection, DMC charters for industry trials now often cover indemnification clauses.

However, there is no indemnification yet for government-sponsored trials. For example, in NCI's guidance, it is specified "The government is prohibited by statute from indemnifying any party without specific legislative authority and consultation with the United States Department of Justice. Government liability for its own actions is usually limited by the Federal Tort Claims Act."

So what is 'indemnification'?

According to Wikipedia, "An indemnity is a sum paid by A to B by way of compensation for a particular loss suffered by B. The indemnifying party (A) may or may not be responsible for the loss suffered by the indemnified party (B). Forms of indemnity include cash payments, repairs, replacement, and reinstatement."

In the United States, Indemnification is a legal document laying down the legal protection or exemption from liability for compensation or damages from a third party, investigator and/or hospital or institution from claims made by the study subject (or relatives) that harm
was caused to the subject as a result of participation in the clinical trial.

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