Functions

♦ Monitoring all aspects of the progress of the trial and reviewing its progress and the quality of the data regularly

♦ Reviewing confidential data from interim analyses, usually unblinded by treatment group, provided by the trial management group, after requesting any additional analyses or information they need to make their assessment

♦ Reporting to the trial steering committee and making recommendations on the continuation ofthe trial

♦ Considering any requests for the release of interim findings, making recommendations to the trial steering committee on the advisability of this

♦ Responding to specific requests from the trial steering committee, particularly about the need for additional support, and making recommendations to this committee and to the sponsor preferable to seek advice from such groups on specific topics as and when required rather than during a data monitoring meeting.

Functions

Monitoring the progress of the trial At their first meeting, relatively early in the course of the trial, it is useful for the committee to meet and agree with the trial management group the planned recruitment targets and the information they will need for assessing the progress of the trial. They should then usually meet at least annually, but if a trial is running well, without problems, discussion of its progress maybe quite brief.

Meetings of the committee are usually organized by the trial management group, but the committee themselves can decide when and how often to meet. The trial management group provide the information and analyses on the progress of the trial. In reviewing its progress, the committee should pay particular attention to answering the following questions.

♦ Is the trial recruiting patients at a satisfactory rate? If not, are the likely reasons discernible? Can they be corrected?

♦ Is the protocol being adhered to? Are the patients eligible? Are they receiving their allocated treatment regimens? Is unexpected toxicity being encountered? Is the safety of patients being compromized? Are collaborating centres providing the data?

♦ Is the trial likely to be completed within the planned timescale and budget? If not, the likely reasons should be identified and the sponsor informed as soon as possible.

♦ Is the trial still relevant? Does information from other sources, or do the results of other related trials, make it desirable to consider whether or not to continue with the present trial?

♦ Are the current results of the trial sufficiently convincing to persuade the members of the committee that the intake should be stopped or the protocol changed?

An agreed person should draft minutes of all meetings and reports, and ensure that members of the committee agree them.

Reviewing confidential interim analyses The analyses reviewed will usuallybe unblinded by treatment group and are therefore confidential, although, for the sake of security, the treatment groups may be identified merely as 'A, 'B', etc. in the written report and tables and the committee told verbally what the groups are. The results of the analyses must not be conveyed to any of the clinicians, expert advisers, or independent assessors involved in the trial. Indeed, unblinded analyses will often be undertaken by the trial statistician alone and even other members of the team will not be aware of the results. Confidentiality is essential to prevent hasty and inappropriate conclusions being drawn from analyses of immature data.

The committee must ensure that they have all the information they need for making recommendations about the progress of the trial. The trial statistician, or other appropriate member of the team, should be available to attend part of the meeting to present the analyses and in order that the committee can ask for clarification or further information if required. Other members of the trial management group may be asked to attend an open part of the meeting to discuss information apart from the unblinded

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