Learning from OCTET - Exploring the Acceptability of Clinical Trials Management Methods

Background Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focusing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring, and closure. Lessons are also frequently learnt during the development and conduct of trialsbut rarely shared for the benefit of others. For the wider research team, the key focus will always be on the execution and delivery of a study. The aim of this study was to evaluate the acceptability of clinical trials management methods, focusing on study execution and monitoring, as implemented in the National Institute for Health Research Health Technology Assessment Programme funded Obsessive Compulsive Treatment Efficacy Trial (OCTET). Methods Workshops, questionnaires and semi-structured interviews were used to explore acceptability of trial management methods with members of the OCTET Trial research team. Nine members participated in the focus group, 10 completed a questionnaire and 20 were interviewed as part of qualitative work for the main OCTET study. Data was collected and analysed using thematic analysis. Results Six key themes were identified: support; communication; processes; resources; training and ethos. Clear and open communication,enthusiasm and accessibility of the trial managers and Chief Investigator were consistently noted as an important facet of the successful running of the trial. Clear resources and training materials were also found to be crucial in helping staff to work within the trial setting. Constructive suggestions were also made for improvement of these resources, for example including both checklists and flowcharts within trial processes. Conclusion Organisation, openness, and positivity are crucial for executing a trial successfully, whilst clear and focused processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study. Trial Registration: Clinical Trial Registry: ISRCTN73535163, Date of Registration: 05.04.2011, Prospective registration. Key Words: Randomised controlled trial, project management, trial management, qualitative