Clinical trial sponsors and investigators continue to face difficulties meeting recruitment goals, and the challenges appear to be increasing. Many explanations have been offered for why trials fail to recruit adequate numbers of participants. Little has been done to systematically examine recruitment obstacles, or share practices for overcoming them. Actionable solutions are needed since, without them, the promise of many trials will remain unfulfilled. It is time to move recruitment planning upstream and parallel to the clinical trial design process to ensure trial feasibility given the anticipated scientific, environmental, financial, time, and resource constraints.
According to CTTI survey results, identifying patients who meet eligibility criteria is the primary barrier to meeting recruitment goals. While medical record and hospital-based registry/database review can be employed to increase enrollment rates, no single tool or method alone will be sufficient to address the range of significant barriers identified. Therefore, a new mindset regarding participant recruitment must be adopted. Participant recruitment must be considered at the initial outset of trial planning, and evidence-based trial feasibility, site selection and communication strategies must be taken into account. Approaches to improve recruitment are outlined in the CTTI Recommendations for Strategic Recruitment Planning.
Recruitment is a critical factor that can determine the success or failure of a clinical trial, and a staggering number of clinical trials continue to fail to meet recruitment goals despite previous efforts. Sub-optimal trial recruitment directly translates into missed opportunities for patients who can benefit from clinical trials, the chance to advance the science and understanding of disease and find new therapies, as well as wasting time, funds, and other resources. Many explanations have been offered to elucidate the failure to recruit adequate numbers of patients including poor study design, lack of patient engagement, insufficient staff time, inadequate attention to determine and identify available patients who meet eligibility criteria, and inadequate centralized site support.
While various approaches have been taken to address recruitment challenges, relatively little has been done to bring together the strategies, resource considerations, and/or stakeholder perspectives that are needed to help plan for efficient and effective recruitment. Furthermore, since recruitment activities are often iterative processes during a clinical trial, adopting a systematic framework early in study planning likely can facilitate subsequent actions. Actionable solutions are needed to inform best practices for trial recruitment processes.
Recruitment (2013- Ongoing)
Address the barriers to recruitment of patients in clinical trials through the identification of solutions to those barriers.
This project has 2 workstreams with distinct objectives:
Recommendations and results from this project will facilitate more efficient and effective enrollment to clinical trials through the use of systematic, well-informed, tailored recruitment planning processes.
Barriers identified by survey respondents included the following, in order of significance:
Medical record and hospital-based registry or database review were methods that survey respondents felt were most effective and most often successfully employed to improve recruitment; however, no single tool or method alone will be sufficient to address the range of significant barriers identified.
Potential solutions proposed by the respondents to address recruitment barriers included increasing education, leveraging technology, obtaining patient/community input, improving planning and budgeting efforts, and streamlining aspects of the study. The most frequent recommendation for identifying eligible patients was to engage in effective study planning, including appropriate site selection.
Following the literature review and survey, recommendations were developed, which details strategic approaches to enhance recruitment across all stages of clinical trial planning. The recommendations contain the following broad suggestions for improvement:
|Project Manager||Jamie Roberts||Clinical Trials Transformation Initiative|
|Team Leader||Jonca Bull||Food and Drug Administration|
|Team Leader||Pat Furlong||Parent Project Muscular Dystrophy|
|Team Leader||Elizabeth Mahon||Johnson and Johnson Pharmaceutical Research and Development|
|Team Member||David Ciavarella||CR Bard, Inc|
|Team Member||Beth Harper||Consultant|
|Team Member||Grant Huang||United States Department of Veterans Affairs|
|Team Member||Adwoa Hughes-Morley||University of Manchester|
|Team Member||Leslie Kelley||Duke University|
|Team Member||Barbara LeStage||Individual Patient/Caregiver|
|Team Member||Holly Massett||National Institutes of Health|
|Team Member||Kelly McKee||Eli Lilly|
|Team Member||Ashish Oza||St Jude Medical|
|Team Member||Anuja Rastogi||Food and Drug Administration|