One of these funded projects focused on diagnostic studies, whilst this project and a separate ethnographic study focused on TSCs for clinical trials.
#Http toolkit projects project steering committees trial
This was one of three projects funded by the MRC Hubs for Trials Methodology Research Network on Trial Steering Committees.
We aimed to explore the roles and responsibilities of the TSC from the perspective and experience of an expert panel of clinicians, trial methodologists and statisticians, and to use this to inform revision of the MRC TSC terms of reference. However, many modified the MRC guidelines from other sources and their own experiences, suggesting that the TSC terms of reference should be updated. These guidelines have been used in the development of local terms of reference by the majority of UK Clinical Trials Units (CTUs) who, in a recent survey, reported having TSC terms of reference in place. The MRC TSC terms of reference, an appendix of the 1998 MRC guidelines for Good Clinical Practice, describe the role of the TSC as providing the overall supervision of the trial. The remit, objectives and functionality of the TSC is usually described and documented in the TSC terms of reference. The appropriate executive committee that considers these recommendations is the Trial Steering Committee (TSC), yet, to date, no such in-depth project establishing the role, responsibilities, and organisation of this committee has been conducted. The DAMOCLES study concluded that the role of the DMC, as indicated within their Charter, is not to make decisions about the trial but rather to make recommendations to an appropriate executive committee.
Members of the TMG are not independent from the trial all members of the DMC are independent and the TSC has both independent members and members who are also part of the TMG.Įxtensive work as part of the DAMOCLES study has been done to establish why and when DMCs are needed their roles, responsibilities and structure their organisation and their decision-making and reporting arrangements.
The TMG is responsible for the day-to-day delivery and conduct of the trial the DMC role is to review safety and efficacy data and make recommendations to an executive group and the TSC is the executive decision-making group that considers the recommendations from the DMC. The Medical Research Council (MRC) Guidelines for Good Clinical Practice (1998) defines a three-committee oversight structure that has been widely adopted in the UK: the Trial Management Group (TMG), the Data Monitoring Committee (DMC) and the executive Trial Steering Committee. Independent oversight committees are recommended in the management of clinical trials.
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