Independent data monitoring and supervision

All randomized trials, whether they are multi-centre or conducted within a single hospital or local group, require data monitoring and supervision by individuals who are independent in the sense that they have no conflict of interest with any aspect of the trial. The trial sponsor (see Section 7.4.1) is responsible for ensuring that independent data monitoring and supervision are provided. The data monitors, usually called the data monitoring and ethics committee or other similar title, assess the progress of the trial in the light of confidential interim analyses and make recommendations to the trial supervisors. The supervisors provide overall supervision of the trial and ensure that it is conducted in accordance with the agreed standards (see Section 7.3). The trial sponsor may delegate to the supervisors the responsibility of deciding whether a trial should be continued, modified, or stopped prematurely. Both data monitors and supervisors must give high priority to patient safety.

Independent data monitoring and supervision can be provided in a number of ways. They are often provided by a single committee, the data monitoring and ethics committee, but supervision may be provided separately by the sponsoring organization, by one or more members of the host institution, or by a trial steering committee, responsible for making decisions about the conduct of the trial in the light of recommendations from a purely advisory data monitoring and ethics committee. The point at issue is who is responsible for making recommendations about continuing, modifying or terminating the trial, and who is responsible for taking the final decision. This must be made clear.

We describe the membership and functions of the data monitoring and ethics committee and the trial steering committee separately below, recognizing that their functions will sometimes be undertaken together by a single committee.

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