17 January 2018
Researchers from the Centre for Academic Primary Care have been involved in a study examining how the oversight of clinical trials is implemented to inform future guidelines for those planning and conducting trials.
They found that relationships between stakeholders involved in trial oversight are central to the process and quality of that oversight, while lack of clarity regarding responsibilities, accountability and lines of communication threatens trial oversight.
Trial oversight in the UK is informed by the Medical Research Council’s (MRC) Guidelines for good clinical practice in clinical trials, published in 1998. These need updating to reflect advances in trial conduct. Clinical Trials Units (CTUs) now play an important oversight role, and recent evidence points to ambiguity and confusion regarding the roles of different stakeholder in trial oversight.
They make 10 recommendations for improving trial oversight.
Read the Trial oversight - research summary (PDF, 246kB).
Further information
Paper: Daykin A, Selman LE, Cramer H, McCann S, Shorter GW, Sydes MR, Gamble C, Macefield R, Lane JA, Shaw A. We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact. Trials 2017; 18:612.
Funding: This work was funded by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (HTMR) (MR/L004933/1-R34) with the support of the MRC ConDuCT Hub (Collaboration and innovation in Difficult or complex randomised Controlled Trials – G0800800).
Contact: Dr Lucy Selman, Research Fellow (Qualitative Research in Randomised Trials) – lucy.selman@bristol.ac.uk, @Lucy_Selman
