QuANTOC study

A qualitative study of group decision making and member roles to understand and improve how Trial Oversight Committees contribute to trial conduct (QuANTOC)

Background: Regulatory bodies require that there is oversight of all aspects of trial set up and conduct. Trial Oversight Committees usually take the form of Data Monitoring Committees (DMCs), Trial Steering Committees (TSCs) and Trial Management Groups (TMGs). The HTA DAMOCLES project resulted in a charter for Data Monitoring Committees, but there is currently little empirical evidence regarding how TSCs and TMGs oversee trials and make decisions about trial conduct. The QuANTOC (Qualitative Analysis of Trial Oversight Committees) study has been funded by the MRC Network of Hubs for Trials Methodology Research to examine the decision making of TSCs and TMGs and how they contribute to ‘challenging’ decisions about trial conduct. The study started in February 2013 and will end in March 2014.

The objectives of QuANTOC are:

1. To understand decision-making processes and member roles in Trial Steering Committees and Trial Management Groups and how they contribute to trial conduct using ethnographic methods.

2. To contribute to updates to the MRC Terms of Reference for Trial Steering Committees and Trial Management Groups.

Methods: Using ethnographic methods we are examining the role of TSCs and TMGs and how they make decisions regarding trial conduct in a purposive sample of eight trials across the UK that are facing ‘challenging’ decisions about trial conduct. Trials have been selected via registered trials units and Funders, to represent a range of trial designs, patient populations, settings, interventions and oversight structures. Non-participatory observation of TSC and TMG meetings is being triangulated by follow-up in depth interviews with committee members and evaluations of trial documentation.

Results: Data analysis is ongoing and the study will be completed at the end of March 2014. Final conclusions and recommendations will be formulated once data analysis is complete. Recommendations from this research and a parallel quantitative study led by Gamble and colleagues at the University of Liverpool will inform updates to the MRC terms of reference for TSCs and TMGs.