Reducing Patient Burden in Clinical Trials Through the Use of Historical Controls: Appropriate Selection of Historical Data to Minimize Risk of Bias

Author:

Lim Jessica,Wang Li,Best Nicky,Liu Jeen,Yuan Jiacheng,Yong Florence,Zhang Lanju,Walley Rosalind,Gosselin Alice,Roebling Robert,Viele Kert

Publisher

Springer Science and Business Media LLC

Subject

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

Reference35 articles.

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3. Lim J, Walley R, Yuan J, et al. Minimizing patient burden through the use of historical subject-level data in innovative confirmatory clinical trials: review of methods and opportunities. Ther Innov Regul Sci. 2018;52(5):546–59. https://doi.org/10.1177/2168479018778282.

4. Viele K, Berry S, Neuenschwander B, et al. Use of historical control data for assessing treatment effects in clinical trials. Pharm Stat. 2014;13:41–54. https://doi.org/10.1002/pst.1589.

5. Food and Drug Administration Center for Devices and Radiological Health (FDA CDRH). Guidance for the use of bayesian statistics in medical device clinical trials. Rockville, MD. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-use-bayesian-statistics-medical-device-clinical-trials-pdf-version. 2010.

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