Engaging internal sponsor partners (e.g. biostatisticians, pharmacovigilance) and external partners, such as patients, clinical investigators and other site staff, IRBs/IECs, operational partners, and regulators – 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:

• Lack of comprehensive resources for engagement (most resources focus solely on sponsors engaging with patients) in trial design.
• Most approaches assume patients and other collaborative partners will be engaged separately (e.g., via patient advisory boards) rather than having all ‘at the table’, as emphasized by Quality by Design.
• The clinical trials enterprise lacks a unifying framework, especially one tied to regulatory guidance, delineating how the various existing engagement methods can be used collectively and coherently across the trial design process.

CTTI’s work in this area will create an engagement roadmap with resources to help engage all collaborative partners in the design of clinical trials.

Collaborative Engagement in Clinical Trial Design

As part of this work, CTTI will:

• Identify specific opportunities and existing high-value approaches/methods/tools for study designers to engage with internal and external partners across the clinical trial design and planning process.
• Identify situation-specific considerations for ensuring engagement is appropriately equitable, effective, and feasible.
• Assess the extent to which draft products address engagement needs, and incorporate feedback into final project output.

By ensuring all collaborative partners are engaged in the design of clinical trials in a way that is equitable, effective, and feasible to implement, research sponsors will consistently conduct more efficient, higher quality trials – meaning trials that:

• Address clear and meaningful scientific questions that are determined with the input and consideration of those who will use the results.
• Are streamlined and efficient to execute, targeting resources to the most critical areas, eliminating nonessential activities, and ensuring validity and feasibility prior to conduct.
• Are safe, accessible and minimally burdensome for participants.
• Generate robust actionable data for regulatory decision-making purposes.

Iterative evidence gathering and design activities are planned to include a landscape scan, user-testing of a draft Engagement Roadmap, formal research aimed at reaching consensus across users on suggested engagement, and one or more expert meetings to review and synthesize findings.

The Collaborative Engagement in Clinical Trial Design project is expected to yield the following:

• Engagement Roadmap identifying detailed, ‘nuts and bolts’ considerations for who and how to engage at each stage of trial planning
• Recommendations for implementation that address practical / operational considerations and barriers (e.g., timelines, contracting) to equitable, effective, and feasible engagement
• Supporting resources for all collaborative partners

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.