Decentralized Trials in the Age of Real‐World Evidence and Inclusivity in Clinical Investigations
Author:
Affiliation:
1. US Food and Drug Administration Silver Spring Maryland USA
2. Harvard‐MIT Center for Regulatory Science Boston Massachusetts USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1441
Reference5 articles.
1. The Center for Information and Study on Clinical Research.Public and Patient Perceptions & Insights Study (2017). Accessed January 17 2019.
2. US Food and Drug Administration (FDA).Framework for FDA's real‐world evidence program (2018). Accessed January 17 2019.
3. Association of patient comorbid conditions with cancer clinical trial participation;Unger J.M.;JAMA Oncol.
4. Use of High-Frequency In-Home Monitoring Data May Reduce Sample Sizes Needed in Clinical Trials
5. INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology
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