Guiding Principles on how Qualitative Research can support Inclusive Trials Methodology

The Q-ASSIST guiding principles will set out how qualitative research can support more inclusive clinical trials. They are organised into six domains, each addressing a challenge that runs across the trial lifecycle, and the roadmap below shows how those domains map onto the twelve stages of a trial.

The principles are being developed with trialists, public and patient involvement partners, and other stakeholders through a consensus meeting. Once they are agreed, the principles for each domain will be published here. For now, you can explore the six domains and the challenges they set out to address.

Roadmap: twelve trial stages, six domains

Each numbered stage marker is coloured by the domain its guiding principles belong to. Select a marker, or a domain in the key, to open that domain’s page.

Trial roadmap: twelve stages coloured by domain A winding road runs from stage 1 at the top to stage 12 at the bottom. Each numbered marker is coloured by the domain its guiding principles belong to and links to that domain’s page. The domain key beside the road lists each colour and domain name. Population definition and sampling strategy Trial preparation and planning Ethical review, consent and governance Community engagement Recruitment, support and retention Data collection and quality management Trial implementation and fidelity Trial oversight and monitoring Training and capacity building Data analysis and interpretation Post-trial access and participant follow-up Reporting and knowledge translation