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 loss of a chance to advance the science and understanding of disease and find new therapies, as well as wasted 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 (2013-2016)

The project aims to address the barriers to recruitment of patients in clinical trials. This project has two work streams 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.

• Literature review
• Survey
• Expert Meeting

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 is 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 that detail 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, 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.)
  • 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.)

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.