Barriers and Facilitators of Platform Trials

Area of Science:

• Clinical Trials Methodology
• Health Services Research

Background:

• Platform trials represent an innovative, resource-efficient clinical trial design.
• Despite their growing importance, the practical challenges faced by platform trial teams are not well understood.

Purpose of the Study:

• To investigate the perspectives of platform trial teams on the barriers and facilitators encountered during trial conduct.
• To identify key factors influencing the successful implementation of platform trials.

Main Methods:

• A cross-sectional survey was distributed to 127 principal investigators and 11 other stakeholders experienced in platform trials.
• Mixed-methods analysis, including descriptive statistics and qualitative content analysis, was applied to survey data.
• The survey was conducted between June and August 2023, with data analyzed post-collection.

Main Results:

• Forty surveys were completed, with respondents representing trial management, principal investigators, statistics, and data management roles.
• Key advantages included efficacy gains from shared infrastructure, but increased planning time and expertise were noted.
• Significant challenges arose from regulatory and organizational processes not designed for adaptive, open-ended platform trials.
• Facilitators identified included targeted support such as guidelines, templates, funding, and infrastructure development.

Conclusions:

• The current clinical research environment presents substantial obstacles for adaptive platform trials due to systemic misalignment.
• Concerted action from stakeholders is necessary to facilitate the integration and successful execution of platform trials.
• Addressing regulatory and organizational incompatibilities is essential for realizing the full potential of platform trials.