Participant recruitment and retention from vulnerable populations in clinical trials is a matter of trust.

ABSTRACT

Clinical research sites can struggle with recruiting and retaining vulnerable populations. Vulnerable research participants often have significant trauma histories making traditional approaches to recruitment and retention tenuous. Due to these difficulties, vulnerable populations are often intentionally excluded from clinical research due to the additional time and work involved. While it is important to provide protections for any participant that has decreased autonomy or increased susceptibility to coercion, it is equally important to assure that individuals in vulnerable populations have access to any clinical research that might pertain to them. In addition, the new trends in the drug development industry including early-stage development, risk-identification, preventative care, and disease spread modeling are likely to include health disparate patient populations that have increased probability of vulnerability. In this article we discuss the roots of many vulnerabilities and how to foster trust for more effective recruitment and retention of vulnerable populations.