心血管疾病的去中心化临床试验：临床试验医师的引物。
Baudry, G., Kulkarni, P., Biering-Sørensen, T., DeVore, A.D., Gibson, C.M., Granger, C.B., & Spall, H.G.C.V. (2026). Decentralized clinical trials in cardiovascular disease : A primer for clinical trialists.. Nat Cardiovasc Res. https://doi.org/10.1016/j.ahj.2023.02.009
Baudry G, Kulkarni P, Biering-Sørensen T, DeVore AD, Gibson CM, Granger CB, et al. Decentralized clinical trials in cardiovascular disease : A primer for clinical trialists.. Nat Cardiovasc Res. 2026; doi: 10.1016/j.ahj.2023.02.009
Baudry G, Kulkarni P, Biering-Sørensen T, et al. Decentralized clinical trials in cardiovascular disease : A primer for clinical trialists.[J]. Nat Cardiovasc Res. 2026. DOI: 10.1016/j.ahj.2023.02.009.
@article{baudry2026,
author = {Guillaume Baudry and Prashanth Kulkarni and Tor Biering-Sørensen and Adam D DeVore and Charles Michael Gibson and Christopher B Granger and Harriette G C Van Spall},
title = {Decentralized clinical trials in cardiovascular disease : A primer for clinical trialists.},
journal = {Nat Cardiovasc Res},
year = {2026},
doi = {10.1016/j.ahj.2023.02.009},
note = {PMID: 41844862},
}
TY - JOUR AU - Guillaume Baudry AU - Prashanth Kulkarni AU - Tor Biering-Sørensen AU - Adam D DeVore AU - Charles Michael Gibson AU - Christopher B Granger AU - Harriette G C Van Spall TI - Decentralized clinical trials in cardiovascular disease : A primer for clinical trialists. T2 - Nat Cardiovasc Res PY - 2026 DO - 10.1016/j.ahj.2023.02.009 AN - PMID:41844862 ER -
Decentralized clinical trials (DCTs) move trial activities-such as recruitment, consent, delivery of the intervention, data collection and assessment of outcomes-away from traditional research sites to the homes or communities of patients. This participant-centered approach is accomplished through the use of digital health technology, remote monitoring, electronic data capture, and home- or community-based procedures. The advantage of DCTs may include broader trial recruitment pools with greater representativeness, reduced participant burden, greater operational efficiency and the ability to generate evidence in real-world settings. These features are particularly relevant in cardiovascular disease, which imposes a disproportionate population burden in regions where clinical trial centers are lacking. In this Perspective, we outline the essential components of the DCT ecosystem, discuss how DCTs can address key challenges in cardiovascular disease research, and using case examples, highlight operational and regulatory considerations in designing fully or partially (hybrid) decentralized trials. We also review the potential risks of DCTs and propose mitigation strategies to ensure high-quality, safe and reliable trial execution.