Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials.

ABSTRACT:

Background

It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials.

Methods

Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) 'roundtable' discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS

SUBMITTER: Biggs K 

PROVIDER: S-EPMC11445965 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature