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

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

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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