Trial run-ins are used as an enrichment strategy in later-phase clinical studies to select participants based on certain factors or characteristics, including their adherence to investigational medicinal products. A recent review found that medication adherence is poorly characterized and reported during the run-in phase of drug trials, with the methods used often liable to bias. The findings of this review, coupled with the lack of specific guidance on trial run-in phases from regulatory authorities highlights the need for a guideline on best practice for the measurement, analysis and reporting of medication adherence during the run-in phase of drug trials.
This Delphi study aims to develop consensus around the methods and reporting of adherence in trial run-ins. The survey is open to anyone self-identifying as having expertise / (≥ 5 years' experience) in medication adherence research; or trials methodology research; or regulatory drug trials.
Participation involves rating the importance of items across a Likert scale of 1 (Strongly disagree) to 5 (Strongly agree). The survey is split into 2 parts. Part 1 covers methodological considerations, and part 2 covers reporting items. You will also be able to provide free text comments and suggest new items. The round 1 survey contains a total of 29 items.
The Participant Information Sheet is available at Pariticpant information sheet
The Privacy Policy is available at Privacy policy
This survey will remain open until the 27/6/2025.
Thank you for your participation. Please follow this LINK to continue.