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About the Q-ASSIST study

In recent years, equity, diversity and inclusion (EDI) have become a growing priority in clinical research. In response, funders, regulatory bodies, and networks have developed guidance to support more inclusive trial practices. However, it remains unclear how well this guidance works in practice, whether it provides adequate guidance across the entire trial lifecycle, or to what extent it is being incorporated in practice.

The Q-ASSIST study began with a core idea that qualitative research has untapped potential to support more inclusive clinical trials. Despite this potential, there is little structured guidance on how qualitative methods can be systematically applied to support EDI in clinical trials. The QuAlitative reSearch Supporting IncluSive Trials (Q-ASSIST study) was developed to address this gap by exploring how qualitative methods can support inclusivity across all stages of a clinical trial.

How the study has unfolded

  1. 1

    Focused Mapping Review and Synthesis

    What we did. We reviewed 15 guidelines that offer recommendations for inclusive trial design and conduct, and mapped 183 recommendations to produce the Q-ASSIST Trial Stages Model, the 12-stage framework of the trial lifecycle.

    What we found. Inclusion guidance is concentrated in the early stages of a trial, with later stages addressed far less.

  2. 2

    Revisiting the O’Cathain et al. (2013) framework

    What we did. We compared the Q-ASSIST Trial Stages Model with O’Cathain et al.’s (2013) framework of how qualitative research has been used within randomised controlled trials.

    What we found. Three stages are particularly under-addressed: trial oversight and monitoring, post-trial access and participant follow-up, and training and capacity building.

  3. 3

    Identification of Case Studies via Horizon Scan

    What we did. We carried out a horizon scan to see whether and how qualitative methods have been applied in the three under-addressed stages (trial oversight and monitoring, post-trial access and participant follow-up, and training and capacity building) since O’Cathain et al.’s 2013 framework, identifying 29 studies.

    What we found. Qualitative work is growing in oversight and training, but it is not usually designed with inclusion in mind, and post-trial follow-up remains largely unexamined.

  4. 4

    Mixed-methods Survey

    What we did. We surveyed people across the trial community. For each of the 12 trial stages, respondents rated how far they agreed that qualitative research has the potential to enhance inclusion at that stage, and how important it is to develop formal guidance on using qualitative research to support inclusive trials methodology. They also described their own experiences of using qualitative methods to support inclusion, or the barriers they had met.

    What we found. Across all roles and all 12 stages, respondents agreed that qualitative research has the potential to make trials more inclusive, with the strongest agreement at recruitment and community engagement. They rated the need for formal guidance on using qualitative research to support inclusive trials methodology lower at the later stages, where the qualitative work they described was usually aimed at improving trials in general rather than at inclusion specifically.

  5. 5

    Grouping the findings into Six Domains

    Looking across all 12 stages together, the most important patterns cut across the whole trial lifecycle rather than being confined to individual stages. We grouped findings that address the same underlying challenge in using qualitative research to support inclusive trials methodology into six domains.

  6. 6

    Developing Guiding Principles Upcoming

    Coproducing guiding principles on how qualitative research can support inclusive trials methodology, with trialists, PPI partners and other stakeholders.

Six domains of guiding principles Upcoming