학술논문

Clinical Trials for Special Populations: Children, Older Adults, and Rare Diseases
Document Type
Academic Journal
Source
Mayo Clinic Proceedings. February, 2024, Vol. 99 Issue 2, p318, 18 p.
Subject
United States
Language
English
ISSN
0025-6196
Abstract
Research cannot maximize population health unless it improves health for all members of the public, including special populations such as children, older adults, and people living with rare diseases. Each of these categories require special considerations when planning and performing clinical trials, and common threads of ethical conduct of research in vulnerable populations appear throughout. In this review, definitions of each of the three categories of special population (children, older adults, and rare diseases) are discussed in terms of US research regulations, the unique challenges to conducting clinical trials for these special populations, critical ethical issues, and opportunities for innovative ways to design and operationalize clinical trials in special populations. Additional critical attention is focused on factors that influence the generalizability of study results to reduce health disparities, as well as the importance of community engagement and advocacy groups that can help to educate potential trial participants of the benefits of clinical trial participation.
As part of the "Forward Thinking on Clinical Trials" Thematic Review Series, we focus on special populations --children, older adults, and patients with rare diseases. The needs of each of [...]