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VA RESEARCH QUARTERLY UPDATE
This Issue: Chronic Disease Care | Table of Contents: Spring 2018

New Initiatives | Announcements

Proposing a new framework for clinical trials recruitment


Researchers are looking for better ways to encourage Veterans to enroll in clinical trials. (Photo for illustrative purposes only. ©iStock/Steve Debenport)
Researchers are looking for better ways to encourage Veterans to enroll in clinical trials. (Photo for illustrative purposes only. ©iStock/Steve Debenport)

Researchers are looking for better ways to encourage Veterans to enroll in clinical trials. (Photo for illustrative purposes only. ©iStock/Steve Debenport)

Recruiting for clinical trials can present many challenges for researchers. For this reason and others, the Clinical Trials Transformation Initiative (CTTI) was created to "develop and drive adoption of practices that will increase the quality and efficiency of clinical trials." CTTI comprises more than 80 member organizations, coming from government, private industry, professional societies, patient advocacy groups, and others.

The CTTI convened a project team to come up with actionable recommendations for improving the clinical trials recruitment process. The team included Dr. Grant Huang, director of the VA Cooperative Studies Program, and stakeholders from Eli Lilly, Janssen, Duke University, and the Association of Clinical Research Professionals. They came together to examine the challenges and barriers to successful clinical trials recruitment and to create a strategic plan to improve the recruitment process going forward.

In a paper published February 2018 in Contemporary Clinical Trials, the project team noted that despite the importance of patient recruitment to successful clinical trials, many researchers fail to meet patient recruitment goals. In a 2015 analysis, investigators found that 19 percent of clinical trials failed to meet recruitment targets and were closed down or terminated early. In addition, clinical trials commonly have difficulty recruiting patients within an allotted time period—the authors say 86 percent of clinical trials do not reach their recruitment targets in time.

The clinical trial planning and design phases can be a critical time to address factors that can positively affect later recruitment efforts, they said. The project team identified multiple factors that could improve CT recruitment efforts. Important areas to consider, they said, are better trial design; adequate staffing; targeted recruitment strategies; participant convenience; financial support for patient recruiters; and incentives and/or compensation for participation.

After collecting input from a literature review, web survey, and expert interviews, the project team concluded that creating a strategic framework to guide a CT recruitment plan was better than just addressing individual activities and tools. To that end, they developed a list of evidence-based recommendations that fell under three broad areas: trial design and protocol development; trial feasibility and site selection; and communication. Recommendations included limiting protocol complexity, establishing realistic metrics, and developing tailored patient messaging.  


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