Effective subject recruitment is the cornerstone of clinical research. Delays in patient recruitment cost pharmaceutical companies
time and money. According to a recent report in Cutting Edge Information, clinical trials last 42% longer than expected in
Phase I, 31% longer in Phase II, and 30% beyond planned deadlines in Phase III—all because of recruitment delays.1 Each day a drug is delayed from market, sponsors lose up to $8 million.2 While it can be challenging to reach a general audience for clinical trials, it is much more difficult to target "special
populations" and motivate them to participate. Special populations are defined as specific ethnic and demographic groups,
such as women, seniors, children, African Americans, Native Americans, and Hispanics.
Percentage of special populations without insurance
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As clinical trials become more complex and specific, protocols increasingly require recruitment of special populations. While
these groups have been historically underrepresented in clinical research, their participation is critical to the success
of many medical research studies and to the evaluation of marketed pharmaceutical and medical products.
Furthermore, it has been mandated that minorities be adequately represented in clinical research.3 The National Institutes of Health (NIH) Revitalization Act went into effect in 1993, requiring that NIH-sponsored clinical
research include women and members of minorities and their subpopulations to determine whether the investigational product
will affect them differently.4 Although this mandate does not apply to all clinical research, it does emphasize the importance of ensuring diversity in
clinical research. Despite this mandate, special populations are still not being recruited into studies efficiently and effectively. According
to Michael Kritschgau, director of late-phase feasibility and development at Radiant Research, a recent Medstat survey entitled
"What Patient Recruitment Methods Work Best for Women and Minorities" found that: "Industry efforts to enroll minority volunteers
in trials remain unsystematic and unsophisticated."5
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This article outlines specific strategies and important issues to consider when recruiting special populations. It will discuss
the importance of recruiting special populations, the barriers to recruiting them, and some solutions for effectively recruiting
these groups into research studies.
The importance of special populations
There is a view that the industry has historically taken a "one-size-fits-all" approach to clinical research and drug development.
For instance, children have traditionally been given smaller doses of medications that were approved for use by adults but
never tested in children. Women have been treated with medications tested mainly, and sometimes exclusively, on men. There
is now a realization that children might not be treated most effectively with an adult medication and that medication that
works on a man may not work on a woman in the same way. As a result, "the current research climate encourages the active recruitment
of groups that have often been neglected in research. Examples include the inclusion of women and ethnic minorities."6
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