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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 Planning

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Contemporary Clinical Trials

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative, published in Contemporary Clinical Trials


CTTI Presents Recommendations for Recruitment: Moving Recruitment Planning Upstream to Reduce Barriers


Barriers to clinical trial recruitment and possible solutions: a stakeholder survey by Elizabeth Mahon, Jamie Roberts, Pat Furlong, Gina Uhlenbrauck, and Jonca Bull, MD in Applied Clinical Trials

Expert Meeting Materials

Materials from the CTTI Recruitment Project Expert Meeting hosted on November 9 - 10, 2015


Results of an Online Survey of Stakeholders Regarding Barriers and Solutions to Clinical Trial Recruitment

“One of the most valuable aspects from the CTTI work is that we were able to systematically organize all of the planning activities into a simple strategic recruitment planning framework.”

James Michael Causey in Clinical Researcher

“We want to create trials that everyone involved can champion, and that doctors can feel good about engaging their patients in,” says Jamie Roberts, senior clinical project manager for the CTTI Recruitment Project.

The Wall Street Journal

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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.

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:

  • Understanding the barriers and solutions for identifying, engaging, and enrolling patients in trials.
  • Identifying methods and strategies to move recruitment planning upstream in the study development process in order to reduce the number of recruitment barriers designed into clinical trials.

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:

  • Issues identifying patients who meet eligibility criteria
  • Insufficient staff time for recruitment
  • Lengthy and complicated consent forms
  • Meeting protocol requirements other than recruitment criteria.

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:

  • Considerations for participant recruitment must begin earlier on if not at the initial outset of trial planning and take into account the following:
    • Scientific relevance
    • Eligibility
    • Procedural burden
    • Design complexity and data collection
  • An in-depth, evidence-based study level feasibility assessment should be conducted at the time of study question design and protocol development to ensure the target study population exists and can be accessed. The three keys to successful recruitment, with regard to sites, include the following:
    • Thoughtful selection of sites
    • Setting clear expectations with ongoing performance monitoring
    • Mechanisms to provide appropriate feedback
  • Recruitment can be improved with effective communication to the target stakeholders and decision makers, including patients, caregivers, investigative site personnel, and healthcare professionals. Four key elements drive a person’s decision to participate in a trial:
    • Practical Factors (study burden, risk, etc.)
    • Emotional Factors (fear, altruism, trust, personal rewards including access to treatment otherwise unavailable, satisfaction with current therapy, etc.) and
    • Environmental Factors (family and friend opinions, primary care MD, etc.)
    • Logistical and Financial Factors (insurance coverage, out-of-pocket expenses, accessibility to the site, visit schedule and convenience, etc.)

Project Team Members

Rolesort ascending Name Affiliation
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
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
Project Manager Annemarie Forrest Clinical Trials Transformation Initiative