Membership and functions of the data monitoring and ethics committee

The role of the data monitoring and ethics committee is to provide totally independent reviews and recommendations to the trial steering committee on the progress of a trial; see Box 8.5. Their principal concerns are patient safety and the ethics of either continuing or terminating the intake to a trial or of modifying its protocol.

Membership

The defining characteristic of the data monitoring and ethics committee is that they are totally independent of anyone involved in the trial, the sponsor, and any organizations providing support, and have no conflict of interest in its outcome. They have no other involvement in the trial except as members of the committee. They can therefore provide wholly objective advice and make correspondingly objective recommendations to the trial management group, trial steering committee and sponsor. The professional members must be experts in their field with experience in the conduct of clinical trials. Any lay member(s) should be fully aware of the issues involved in conducting trials.

The committee needs to ensure that it has available all information it is likely to need on the day-to-day conduct of the trial, and is able to provide independent review. In addition to an independent chairman and other independent members, it therefore needs to be able to call upon members of the trial management group. It maybe helpful to include a member of a patient advocacy group for part of a meeting, but it is usually

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