Improving feasibility study designs and trial conduct to enhance trial quality and results

In this theme we aim to enhance the design and effective conduct of RCTs through optimising feasibility study designs and evaluating methods to improve trial conduct. Barriers cited to undertaking definitive trials of invasive interventions will be investigated through informative feasibility studies. In addition, methods to improve overall trial conduct will be developed and evaluated empirically.

Aims and objectives

The aims and objectives of this theme are:

• explore methods to standardise invasive interventions and concomitant procedures between trial sites and measure protocol fidelity
• develop methods to assess operator and team expertise in surgical trials
• maximise participant retention and clinical outcome data collection, including adapting and evaluating these methods for surgical trials
• enhance site monitoring and staff training in non-IMP trials
• optimise trial oversight processes by extending ongoing research on the role and function of Trial Steering Committees.