Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework

Author:

Izem RimaORCID,Zuber Emmanuel,Daizadeh Nadia,Bretz Frank,Sverdlov Oleksandr,Edrich Pascal,Branson Janice,Degtyarev Evgeny,Sfikas Nikolaos,Hemmings Robert

Publisher

Springer Science and Business Media LLC

Reference31 articles.

1. National Academies of Sciences. Virtual clinical trials: challenges and opportunities: proceedings of a workshop. Washington, D.C. 2019. https://nap.nationalacademies.org/catalog/25502/virtual-clinical-trials-challenges-and-opportunities-proceedings-of-a-workshop. Accessed 19 Jun 2023.

2. Khozin S, Coravos A. Decentralized trials in the age of real-world evidence and inclusivity in clinical investigations. Clin Pharmacol Ther. 2019;106(1):25.

3. Sharma N. Patient centric approach for clinical trials: current trend and new opportunities. Perspect Clin Res. 2015;6(3):134.

4. Huilai X. Introduction to FDA’s guidance for enhancing diversity of clinical trial populations. Drug Eval Res. 2021;44(6):10.

5. Flores LE, Frontera WR, Andrasik MP, Del Rio C, Mondríguez-González A, Price SA, et al. Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA Netw Open. 2021. https://doi.org/10.1001/jamanetworkopen.2020.37640.

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