Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials

BACKGROUND: Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are not evidence-based, as rigorous methodological research on these issues is rare. The current research sought to identify barriers to the routine implementation of methodology research around recruitment and retention. METHODS: All registered UK clinical trials unit directors were sent a short questionnaire and invited to interview. Representatives of funding bodies and other stakeholders were also approached. Interviews were recorded and the content analysed. RESULTS: Data were grouped into four themes: acceptance of the need for methodological research; trial funding and development; trial processes; and organisational factors. The need to improve the evidence base for trials methodology is well established, but numerous barriers to implementation were perceived. CONCLUSIONS: The knowledge and expertise required to routinely implement methodology research exists within the current research structures, and there are clear opportunities to develop the evidence base. However, for this to be achieved there is also a need for clear strategic coordination within the sector and promotion of the necessary resources.