Academic Journal
Decentralized Clinical Trials in the Era of Real‐World Evidence: A Statistical Perspective
| Title: | Decentralized Clinical Trials in the Era of Real‐World Evidence: A Statistical Perspective |
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| Authors: | Jie Chen, Junrui Di, Nadia Daizadeh, Ying Lu, Hongwei Wang, Yuan‐Li Shen, Jennifer Kirk, Frank W. Rockhold, Herbert Pang, Jing Zhao, Weili He, Andrew Potter, Hana Lee |
| Source: | Clinical and Translational Science, Vol 18, Iss 2, Pp n/a-n/a (2025) |
| Publisher Information: | Wiley, 2025. |
| Publication Year: | 2025 |
| Collection: | LCC:Therapeutics. Pharmacology LCC:Public aspects of medicine |
| Subject Terms: | digital healthcare technology, estimand, remote data acquisition, statistical analysis plan, Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270 |
| More Details: | ABSTRACT There has been a growing trend that activities relating to clinical trials take place at locations other than traditional trial sites (hence decentralized clinical trials or DCTs), some of which are at settings of real‐world clinical practice. Although there are numerous benefits of DCTs, this also brings some implications on a number of issues relating to the design, conduct, and analysis of DCTs. The Real‐World Evidence Scientific Working Group of the American Statistical Association Biopharmaceutical Section has been reviewing the field of DCTs and provides in this paper considerations for decentralized trials from a statistical perspective. This paper first discusses selected critical decentralized elements that may have statistical implications on the trial and then summarizes regulatory guidance, framework, and initiatives on DCTs. More discussions are presented by focusing on the design (including construction of estimand), implementation, statistical analysis plan (including missing data handling), and reporting of safety events. Some additional considerations (e.g., ethical considerations, technology infrastructure, study oversight, data security and privacy, and regulatory compliance) are also briefly discussed. This paper is intended to provide statistical considerations for decentralized trials of medical products to support regulatory decision‐making. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1752-8062 1752-8054 |
| Relation: | https://doaj.org/toc/1752-8054; https://doaj.org/toc/1752-8062 |
| DOI: | 10.1111/cts.70117 |
| Access URL: | https://doaj.org/article/df57a2e515894228a958eed5c9857175 |
| Accession Number: | edsdoj.f57a2e515894228a958eed5c9857175 |
| Database: | Directory of Open Access Journals |
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| ISSN: | 17528062 17528054 |
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| DOI: | 10.1111/cts.70117 |
| Published in: | Clinical and Translational Science |
| Language: | English |