Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

Area of Science:

• Clinical trial management
• Healthcare research operations
• Patient recruitment strategies

Background:

• Patient recruitment is critical for clinical trial success, yet many trials fail to meet enrollment targets.
• Persistent recruitment challenges have significant scientific, financial, ethical, and policy implications.
• Existing strategies have not fully overcome barriers, necessitating a more comprehensive approach.

Purpose of the Study:

• To develop a strategic framework and actionable recommendations for improving clinical trial recruitment planning.
• To address challenges beyond common study-specific strategies through a multi-stakeholder effort.
• To promote an upstream approach to recruitment planning for greater impact and reduced downstream barriers.

Main Methods:

• Convened a multi-stakeholder project team under the Clinical Trials Transformation Initiative (CTTI).
• Examined persistent challenges in clinical trial patient recruitment.
• Developed a framework focusing on trial design, feasibility, site selection, and communication.

Main Results:

• A framework delineating three essential areas for strategic recruitment planning: trial design/protocol development, feasibility/site selection, and communication.
• Actionable, evidence-based recommendations for improving recruitment planning.
• Tools to facilitate the adoption of these recommendations.

Conclusions:

• The proposed upstream framework offers a comprehensive approach to clinical trial recruitment planning.
• Recommendations aim to mitigate downstream recruitment barriers and enhance trial success.
• The framework and tools can guide initial recruitment planning efforts across diverse trials.