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

Published

Journal Article

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach 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 identify 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 examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend 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 produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement.

Full Text

Duke Authors

Cited Authors

  • Huang, GD; Bull, J; Johnston McKee, K; Mahon, E; Harper, B; Roberts, JN; CTTI Recruitment Project Team,

Published Date

  • March 2018

Published In

Volume / Issue

  • 66 /

Start / End Page

  • 74 - 79

PubMed ID

  • 29330082

Pubmed Central ID

  • 29330082

Electronic International Standard Serial Number (EISSN)

  • 1559-2030

International Standard Serial Number (ISSN)

  • 1551-7144

Digital Object Identifier (DOI)

  • 10.1016/j.cct.2018.01.003

Language

  • eng