Background
Research into how best to design, conduct, analyse, and report clinical trials is essential if the evidence generated by trials is to effectively inform decisions about treatment. The results of many of these trials methods projects are not useful if their results are not implemented in future trials. Understanding what makes implementation of this evidence into practice will provide researchers opportunities to enhance implementation in the future and provide areas of uncertainty that require further research.
Aims and Objectives
The overall aim of this study is to generate evidence on what challenges and opportunities trialists perceive with regard to implementation of results from trials methods research that target the design, conduct, analysis or reporting of trials.
The specific research objectives are:
- To leverage existing professional networks to scope existing completed trials methods research across the central aspects of trial design, conduct, analysis, and reporting;
- To determine the broad barriers and facilitators to implementation of trial methods research as perceived by trialists;
- To explore in depth the challenges and opportunities to implementing trials methods research;
- To identify opportunities for future research within this area.
Study Population
Researchers involved in trials methods research and trialists involved in any aspect of the design, conduct, analysis, and reporting of clinical trials.
Methods
This is a sequential exploratory mixed methods design using implementation science methods. Mapping of existing trials methods projects will be collected through expert opinion. Data on challenges and opportunities will be collected using surveys and interviews. The population for surveys will be the Directors (or nominated individuals) of the 52 UK Clinical Research Collaboration (UKCRC) registered Clinical Trial Units (CTUs). Survey responders will be asked to indicate if they would be willing to be contacted about participating in a linked interview. We will aim to interview up to 16 participants. If more than 16 people indicate interest to be interviewed we will sample participants purposively based on experience of implementing trials methods research in their CTU (from little to lots of experience).
Funder: MRC/NIHR Trials Methodology Research Partnership
Chief Investigator: Dr Katie Gillies
Contacts
- Taylor Coffey; taylor.coffey1@abdn.ac.uk
- Katie Gillies; k.gillies@abdn.ac.uk
- Paula Williamson; prw@liverpool.ac.uk