분산형 임상시험에 대한 주제범위 문헌고찰: 임상시험의 분산화 요소 추출과 분산화 정도 탐색

Abstract

Objectives: The purpose of this scoping review was to describe what is the elements of decentralized clinical trial (DCT) across the literature that is report- ing the decentralized clinical trial. And the degree of decentralization was reviewed by the scoping review. Methods: A scoping review of literature pub- lished in English from the first report of literature extracted using the search term ‘Decentralized Clinical Trial’ to 15 September 2024 was conducted. By reviewing the articles selected, the characteristics of the methods performed for decentralization in each study were extracted, and the decentralization factors were categorized according to the common characteristics of the decentralization methods and core categories of clinical trial design and the elements of the distributed clinical trial were analyzed. Application of the search strategy resulted total 1,080 of articles and 80 articles met inclusion cri- teria. Results: This literature identified methods of decentralized clinical trials in terms of recruitment and consent processes, interventions, and mea- surements. The decentralized elements extracted from the methods, were remote recruitment, review of eligibility, enrollment, electronic consent, provi- sion of interventions via telemedicine, remote collection by wearable devices, transport of specimens via logistics chain, direct delivery of drugs/medical devices to subjects, remote collection of patients reported outcome, measurement of clinical trial results via telemedicine, and analysis of real-world data. Conclusions: The Literature includes decentralized elements in the process of enrollment, related to intervention, such as digital interventions and remote interventions, and related to outcome, such as data collection. The scope and degree of application of decentralized elements varied depending on the characteristics of the clinical study.