Functions

♦ Supervising all aspects of the progress of the trial and reviewing its progress regularly

♦ Responding to reports and recommendations from the data monitoring and ethics committee and deciding whether the intake should be continued or the protocol modified

♦ Regularly reviewing relevant information from other sources and on other related trials

♦ Making recommendations to the sponsor and the trial management group on publicizing the trial in the media

♦ Reporting on all aspects of the above to the sponsor about the progress of the trial based on the report and recommendations of the data monitoring and ethics committee.

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

Responding to recommendations of the data monitoring and ethics committee As indicated above, the recommendations of the data monitoring and ethics committee are based on confidential interim analyses, unblinded by treatment group, and on any relevant information from other sources. The data monitoring and ethics committee is particularly concerned with the ethics of continuing the trial and with patient safety. It is the responsibility of the trial steering committee to decide how to respond to these recommendations.

If they decide to comply fully with them, the reasons will have been made clear by the data monitoring and ethics committee. If they decide not to comply with their recommendations, or to comply with them only in part, they must fully justify their decision to the sponsor and make their reasons clear.

At each meeting, the committee should consider whether the intake to the trial should be continued or the protocol modified. If they decide to stop the intake prematurely or make a major modification to the protocol, it is essential that they make their reasons clear, particularly whether their recommendation is made for scientific reasons or because of organizational matters; they should specifically state whether the reasons for undertaking the trial are still valid.

Reviewing relevant information from other sources It is the trial management group who should be best informed on the progress of similar, relevant trials being conducted by other groups and who first become aware of their results. This is because they keep in contact with the groups running these trials and usually attend conferences at which results are presented and discussed. It is the responsibility of the trial management group to ensure that the progress of, and findings from, these trials are discussed by the trial steering committee. In the light of such findings, the committee should consider what, if any, action to take: for example, changing the protocol, collecting additional data, or even terminating the intake.

Making recommendations on publicizing the trial in the media We have discussed above the roles of the trial management group in promoting and publicizing trials within the scientific and medical community and patient advocacy groups (see Section 8.4). There are times, however, when it is appropriate to issue a press release, arrange a press conference or interview, or to inform the media in other ways about the progress or results of a trial. The trial steering committee should consider whether they should make recommendations about such action to the sponsor.

Reporting to the sponsor In reporting to the sponsor after each meeting, the committee should give a full account of the progress of the trial. It should pay particular attention to the following principles.

♦ Justify any decisions taken, in particular those made in response to recommendations from the data monitoring and ethics committee.

♦ Report particularly on patient safety and on the ethics of any decisions made on continuing or modifying the trial.

♦ Indicate the steps that have been taken to obtain information on the progress or results of similar, relevant trials being conducted by other groups.

♦ Give a full account of any complaints or adverse comments that have been made, indicating their source.

♦ Express a clear opinion on whether the trial is likely to be completed within the planned timescale and budget. If this is considered unlikely, either because more patients than originally planned are needed or because the rate of intake has been slow, state whether additional funding over a longer period is likely to be sought, giving full justification if this is so. Indicate, if relevant, the steps that have been taken to keep the trial within the bounds of the originally agreed support.

♦ If additional support over a longer period is considered desirable, ask the trial management group to suggest revised plans.

In fulfilling its functions, the committee have a particular responsibility to patients, ensuring that their rights, safety and well-being are being protected above the interests of science and society.

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