Recruitment and Retention of Women in Clinical Research
The appropriate representation of women in biomedical and biobehavioral research studies, especially clinical trials, is an explicit criterion considered in the review of applications for funding by NIH. But finding and enrolling women in clinical trials and ensuring their retention can be difficult. Some trials never get off the ground because of insufficient recruitment.
This section presents strategies that are relevant to women and translatable across many subgroups of the U.S. population. The literature review presents the primary barriers and facilitators in the recruitment and retention of women, including minority women, in clinical research and looks at a range of studies that address these issues. Some of these studies were designed to determine why women would opt into or out of a trial; others are completed retrospective studies of clinical interventions.
NIH defines research participants as both healthy and patient volunteers. Both are essential to clinical research, so all of the studies presented here include both types of volunteers:
- A healthy volunteer is someone with no known significant health problems who participates in research to test a new drug, device, or intervention as a “healthy volunteer” or “clinical research volunteer.” Healthy volunteers are often essential in clinical research, serving as control subjects for comparative purposes or to establish a normative physiological baseline.
- A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants.
In addition to the literature review, this section includes best practices in recruitment and outreach strategies, as well as case studies highlighting a range of successful techniques and methods that principal investigators have used when recruiting for clinical research.
The ongoing challenge of recruiting and retaining volunteers has prompted studies to identify why recruitment and retention can be so difficult and—more importantly—what can be done about it. This review provides a summary of the literature on the barriers and facilitators to recruiting women from diverse backgrounds to clinical trials.