The trial management group

Once the decision has been made that a new trial should be undertaken, a trial management group should be set up to develop and manage the trial (see Box 7.3). This is essential whether it is a small trial run by a single centre or a large multi-centre collaboration. The differences between small and large trials are those of scale and detail, not of principle, but the conduct of a trial should rarely, if ever, be the responsibility of only one person. The trial management group should include the principal investigator(s), together with the expert advisers who carried the idea through the planning and design stages described in previous chapters. Thus, it is typically the protocol development group who become the trial management group.

It is the trial management group who are ultimately responsible for ensuring that a trial is conducted efficiently, completed successfully, and published promptly. However, by agreeing to collaborate in a trial, the expert advisers and collaborating clinicians all accept responsibility for their own contributions. To be successful, a trial requires good communication, close cooperation, and a high level of commitment from all those involved. All concerned with the conduct of a trial must ensure that every effort is made to promote the trial, to conduct it ethically and safely in accordance with

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