Barriers and Facilitators of Platform Trials

Le résumé fourni par la source

Importance: Platform trials have emerged as a novel approach to clinical trials and are often described as a more resource- and cost-efficient design. Despite their growing relevance, the experiences and challenges of teams conducting platform trials remain underexplored. Objectives: To examine the experiences and views of platform trial teams regarding the barriers and facilitators raised when conducting platform trials. Design, Setting, and Participants: This cross-sectional survey study was carried out from June to August 2023 and was analyzed with a mixed-methods approach. The survey was sent to 127 principal investigators of platform trials and 11 other stakeholders who are experienced in the methodology and conduct of platform trials. The survey could be forwarded to other relevant team members of a platform trial. Main Outcomes and Measures: Survey data on barriers and facilitators to conducting platform trials were analyzed using descriptive statistics and standard qualitative content analysis. Results: A total of 40 completed surveys were returned. Respondents' roles in platform trials included trial management (22 respondents [55%]), principal investigator (12 respondents [30%]), statistics and trial methodology (11 respondents [28%]), and data management (11 respondents [28%]). Respondents reported efficacy gains from using a shared coordinating infrastructure for multiple intervention arms as the key advantage of platform trials, although these require more planning time and greater team expertise than traditional randomized clinical trials. There was no consensus on whether the perceived costs and resources needed for adding a comparison within a platform trial were lower or higher compared with setting up a traditional randomized clinical trial. A repeatedly raised challenge was that current regulatory and organizational processes are set up for intervention-specific clinical trials and are incompatible with adaptive and open-ended platform trials. Targeted supports such as guidelines, templates, funding mechanisms, and infrastructure setup for platform trials were identified as facilitators for their conduct. Conclusions and Relevance: In this survey study of platform trial experts, it was found that the clinical research landscape is currently not set up for adaptive platform trials, which leads to substantial challenges conducting such trials. These findings suggest that stakeholders need to take concerted action to enable the integration of platform trials.

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