New CTTI Project Aims to Engage All Stakeholders in Clinical Trial Design
Engaging patients and all stakeholders from the earliest stages of trial design is increasingly recognized as fundamental to planning and conducting high quality clinical trials. Yet important gaps remain, including a lack of comprehensive resources for engaging all stakeholders and a unifying framework, especially one tied to regulatory guidance.
To address these gaps, CTTI is starting work on a new project that will result in an engagement roadmap, multi-stakeholder recommendations, and supporting resources for effectively and efficiently engaging all stakeholders in the design of clinical trials. This project aims to identify:
- Specific opportunities and high-value approaches/methods/tools for study designers to engage with internal and external stakeholders across the clinical trial design and planning process.
- Situation-specific considerations for ensuring engagement is appropriately equitable, effective, and feasible.
In carrying out this work, CTTI will conduct iterative design and evidence gathering activities, including a landscape scan, user-testing and formal research aimed at reaching consensus across stakeholders on suggested engagement, and one or more multi-stakeholder expert meetings to review and synthesize findings.
By taking a multifaceted approach, CTTI will create resources that will enable clinical trial designers to collectively and coherently use various existing methods to engage all stakeholders across the trial design process – leading to more efficient, higher quality research in alignment with CTTI’s vision for clinical trials by 2030.