Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations

Contemporary Clinical Trials
Volume 84 September 2019
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/84/suppl/C

 

Patient Recruitment
Research article Abstract only
Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations
Luke Gelinas, Brian Crawford, Ariella Kelman, Barbara E. Bierer
Abstract
Clinical trials for investigational new products to treat rare and ultra-rare diseases typically involve a limited number of research sites recruiting from a small pool of patients dispersed over a large geographical area. When remote access is not possible and participants must be present at a trial site, participation in research may require individuals and their families/caregivers to travel great distances, often at significant cost personally and financially and, frequently, for the duration of the trial. This article addresses the ethical and practical issues associated with the practice of sponsors offering financial and other assistance for relocation to trial sites from significant geographical distances, providing both foundational analysis of the ethical issues as well as actionable policy-level guidance on how to best approach these situations.