Journal of Clinical Research and Pharmacy

Journal of Clinical Research and Pharmacy 44 7897 074717

Peer Review Journals Of Clinical Trials

Patient recruitment is widely known as a key determinant of success for clinical trials. Yet a considerable number of trials fail to succeed in recruitment goals—a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to spot and address barriers, recruitment challenges persist.

To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to look at the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that reach beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to supply greater impact and reduce downstream barriers. Additionally, we provide tools to assist facilitate adoption of the recommendations. We hope that our framework and proposals will function a guide for initial efforts in clinical test recruitment planning regardless of disease or intervention focus, provide a standard basis for discussions during this area and generate targets for further analysis and continual improvement.

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