Journal Article

Learning from OCTET – exploring the acceptability of clinical trials management methods

Gellatly, Judith, Arundel, Catherine

2018

Overview

Background Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing 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 trials but 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, focussing 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 focussed 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, ID: ISRCTN73535163 . Registered prospectively on 5 April 2011.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Behavior modification / Biomedicine / Building capacity for evidence informed trial management / Clinical trials / Clinical Trials as Topic - economics / Clinical Trials as Topic - methods / Clinical Trials as Topic - organization & administration / Clinical Trials Data Monitoring Committees - organization & administration / Consent / Cooperative Behavior / Data Accuracy / Efficiency, Organizational / England / Health Sciences / Humans / Interdisciplinary Communication / Medical research / Medicine / Medicine & Public Health / Mental health / Multicenter Studies as Topic - economics / Multicenter Studies as Topic - methods / Obsessive compulsive disorder / Obsessive-Compulsive Disorder - diagnosis / Obsessive-Compulsive Disorder - physiopathology / Obsessive-Compulsive Disorder - therapy / Patient Selection / Planning / Project management / Qualitative / Qualitative Research / Randomised controlled trial / Randomized Controlled Trials as Topic - economics / Randomized Controlled Trials as Topic - methods / Research Design / Research Personnel - economics / Research Personnel - organization & administration / Research Personnel - psychology / Statistics for Life Sciences / Time Factors / Treatment Outcome / Trial management / Workflow