期刊
ORPHANET JOURNAL OF RARE DISEASES
卷 18, 期 1, 页码 -出版社
BMC
DOI: 10.1186/s13023-023-02693-7
关键词
Decentralized Clinical Trials; Clinical Trial; Pilot Study; Rare Disease; Real World Data; Digital Health Technologies; Advanced Analytics
Traditional clinical trials face challenges in recruiting rare disease patients due to their limited number and scattered distribution. Decentralized Clinical Trials (DCT) offer a participant-centric approach that utilizes new technologies and innovative procedures to interact with participants at home, improving trial quality.
BackgroundTraditional clinical trials require tests and procedures that are administered in centralized clinical research sites, which are beyond the standard of care that patients receive for their rare and chronic diseases. The limited number of rare disease patients scattered around the world makes it particularly challenging to recruit participants and conduct these traditional clinical trials.Main bodyParticipating in clinical research can be burdensome, especially for children, the elderly, physically and cognitively impaired individuals who require transportation and caregiver assistance, or patients who live in remote locations or cannot afford transportation. In recent years, there is an increasing need to consider Decentralized Clinical Trials (DCT) as a participant-centric approach that uses new technologies and innovative procedures for interaction with participants in the comfort of their home.ConclusionThis paper discusses the planning and conduct of DCTs, which can increase the quality of trials with a specific focus on rare diseases.
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