CAP: Improving enrollment across NIA-funded clinical studies

The authors thank the members of the NIA CAPs Working Group for their contributions to this blog and development of the overall CAPs policy.

NIA is committed to supporting research on aging that improves the health and well-being of all people. However, one of the biggest hurdles in advancing aging research is recruiting and retaining an inclusive group of clinical research participants.

To address this challenge, NIA has established the Clinical Research Operations & Management System (CROMS) . CROMS tracks enrollment performance of NIA’s clinical research portfolio and reports on extramural clinical research enrollment data in near real time. Using CROMS data, NIA staff and grantees can identify if their clinical trials are meeting participant enrollment targets or if they are behind on key milestones necessary to comply with NIH inclusion policies .

Taking action to assist with enrollment challenges

Earlier this month, NIA also released a Clinical Research Enrollment Policy to help overcome enrollment challenges. For clinical trials with an enrollment rate less than 60% of the study’s planned target(s), the policy requires that the principal investigator provide a Corrective Action Plan (CAP) for enrollment progress.

The CAP will need to include:

  • A summary of the screening and enrollment history of the study
  • An assessment and explanation of factors contributing to recruitment timeline delays
  • The identification of planned actions for remediation of these factors
  • An overall timeline for correction

NIA staff will continue ongoing monitoring, provide additional guidance and support to the grant recipient when applicable, and communicate when critical enrollment progress is achieved.

We’re here to help

The CAP is part of an overarching process that has been established to support investigators in reaching their enrollment targets and improving study progress. Through this policy, we aim to ensure effective stewardship of NIA funding by improving transparency and accountability toward both of these clinical research goals.

For additional information, please see the NIA Clinical Research Enrollment Policy, NOT-AG-24-081 or the CAPs page on the NIA website. If you have questions, please comment below or email Sharon or Melissa for additional information.

Scientific Resources 2024-12-19T00:00:00Z