Each investigative team and each institution will have varying capacities to address minority recruitment in clinical trials. The same is true for each individual research project – varying resources dedicated to recruitment will inform the recruitment strategies used and potentially, the success of recruitment efforts. While the recruitment of study participants to trials, especially cancer therapeutic trials can be challenging, carefully developed recruitment plans informed by frameworks (such as the Ford Model) and by empirical evidence, can be successful. Moreover, opportunities to build the evidence-base for efficacious recruitment strategies remain and should be carefully considered by study principal investigators as a component to include in their research projects.
While in the past, recruitment approaches may have reflected multiple approaches simultaneously implemented, more recently, researchers have begun to systematically examine the factors associated with successful recruitment and retention of racial and ethnic minorities. In a study by Trauth and colleagues in 2005, designed to better understand the factors associated with an older African American woman’s enrollment in a cancer screening trial, the researchers discovered perceived risks and benefits of participation, firsthand experience of a loved one’s cancer, thoughts related to cancer prevention and detection, and clinical trial knowledge or experience with clinical trials all influence willingness to participate in the study. In a randomized trial of recruitment methods for older African American men to this same cancer screening trial, it was found that the most effective recruitment strategy included face-to-face contact (at a church) and addressed individual, study design, economic, and sociocultural barriers. In a process evaluation of a recruitment strategy that included the church and the community, researchers found several components important to recruiting older African Americans. These included alleviating worries of exploitation, establishing a community advisory board, and stressing the independence of participants. While it may be difficult to obtain research funding to test specific recruitment approaches, it may be possible to obtain supplement funding to larger grants to evaluate recruitment approaches or designing research studies to document and empirically evaluate recruitment approaches within the context of the larger study. For example, a paper by Dignan et al., (2011) carefully details the recruitment of primarily African American cancer survivors to a cancer education program trial, highlighting the points along the recruitment continuum where potential participants were retained or lost.
Consider Your Focus
An important consideration is to determine where your focus needs to be when recruiting. Often, recruitment efforts focus on the “awareness” point of the recruitment trajectory. While a necessary point of focus, remaining mindful that individuals may be aware of the trial, yet other factors hinder participation such as the true opportunity to participate (e.g., perhaps not being asked/invited to participate, exclusive eligibility requirements etc.) may influence recruitment. Alternatively, it is possible that the potential participant may be aware of the trial, has the true opportunity to participate, but declines to sign the consent form. It is important for research teams to carefully assess how potential participants move along the recruitment continuum and plan interventions to support and increase recruitment at each time point, with a special focus on areas in which potential participants may be lost to recruitment. The Ford conceptual framework described in detail in the first learning objective of this module, identifies factors (and potential moderators) of recruitment efforts across the recruitment continuum of awareness, opportunity, acceptance/refusal. Assessing these factors, as appropriate, can further improve understanding (and inform recruitment strategies), for research projects.
Developing the Recruitment Pathway
There are various ways of developing capacity to deliver interventions across all three points on the recruitment pathway. Foremost, is having an understanding of the factors that impact each of the points on the recruitment pathway. While published literature is an excellent starting point, designing opportunities to learn from the local community, in a sustained and ongoing way is also of great value. For example, a patient-centered advisory board may provide useful insights to the factors influencing research participation in the local community and can help shape interventions along the research continuum. Point-of-care interviews with cancer patients that accept or decline participation may also provide a lower-cost, and ongoing way to learn about the real-life experiences of cancer patients and trial participation.
A useful starting point in determining how to enhance the recruitment process, might begin with a self-assessment. Assessing your readiness/preparedness, that of the research team, and that of the institution to address the factors associated with research participation might offer insight into current strengths and areas of growth. Please take a few minutes to complete the self assessment that accompanies this module.
A self assessment tool provides feedback regarding areas of strength and areas of growth on both a personal and institutional level readiness to address minority recruitment in clinical trials.