Background: Trials that involve human participants call for experiments or observations that are performed in a clinical research setting. Currently, there are over 16,000 clinical trials open in the United States. Despite continuing efforts to include "special populations" in clinical trials, there are gaps in participation for people who are either minors or elderly adults, are from historically under-represented minorities, or live in rural communities. The inclusion of these special populations in clinical trials research is essential for conclusions that benefit all populations. Data suggest that study participation rates for special populations have fallen to levels that could endanger the successful performance of some types of research. This is particularly concerning in the 21st century, where demographic trends in the United States continue to shift towards an older and Hispanic population with fewer rural dwellers. Trends in New Mexico and other minority-majority states mirror many of these shifts.
Relevance for Patients: In this review, we highlight improvement strategies for enhanced clinical trial participation by members of special populations. Key drivers for disparate clinical trials participation and outcomes often include differences in genetics, physiology, and perceptions of mistrust towards researchers. To overcome these barriers, we focus on best practices in recruitment strategies from the perspectives of the participants, the researchers and the institutions that support clinical trials.
1 Children’s Minnesota Research Institute, Minneapolis, MN, United States
2 Department of Family and Community Medicine, University of New Mexico, Albuquerque, United States
3 Department of Internal Medicine, Division of Epidemiology, Biostatistics and Preventive Medicine, University of New Mexico, Albuquerque, United States
4 UNM College of Nursing, University of New Mexico, Albuquerque, United States
5 University of New Mexico School of Law, University of New Mexico, Albuquerque, United States
6 UNM Clinical and Translational Science Center, University of New Mexico, Albuquerque, United States
Stuart S. Winter
Children’s Minnesota Research Institute 2525 Chicago Avenue South Minneapolis, MN 55404, United States
Department of Experimental Surgery, Academic Medical Center, University of Amsterdam,Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands