Using Electronic Health Records to Derive Control Arms for Early Phase Single‐Arm Lung Cancer Trials: Proof‐of‐Concept in Randomized Controlled Trials-Reference-Cited by-同舟云学术

Using Electronic Health Records to Derive Control Arms for Early Phase Single‐Arm Lung Cancer Trials: Proof‐of‐Concept in Randomized Controlled Trials

Published:2019-10-11 Issue:2 Volume:107 Page:369-377
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Carrigan Gillis¹,Whipple Samuel¹,Capra William B.¹,Taylor Michael D.¹,Brown Jeffrey S.²,Lu Michael¹,Arnieri Brandon¹,Copping Ryan¹,Rothman Kenneth J.³

Affiliation:

1. Genentech South San Francisco California USA

2. Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston Massachusetts USA

3. Research Triangle International Boston Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1586

Reference29 articles.

1. United States Congress.21st Century Cures Act (2016).

2. US Food and Drug Administration.Sentinel initiative (2017). Accessed March 24 2018.

3. Armstrong D.et al.The role of non‐randomized trials for the evaluation of oncology drugs. Conference on Clinical Cancer Research Issue Brief November2014.

4. Cancer Moonshot. Accessed June 10 2018.

5. Multidimensional Evidence Generation and FDA Regulatory Decision Making

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