The use of external controls: To what extent can it currently be recommended?-Reference-Cited by-同舟云学术

The use of external controls: To what extent can it currently be recommended?

Published:2021-04-27 Issue:6 Volume:20 Page:1002-1016
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Burger Hans Ulrich¹^ORCID,Gerlinger Christoph²,Harbron Chris³,Koch Armin⁴^ORCID,Posch Martin⁵,Rochon Justine⁶,Schiel Anja⁷

Affiliation:

1. Pharmaceutical Division, Data Sciences Hoffmann‐La Roche AG Basel Switzerland

2. Statistics and Data Insights, Bayer AG and Gynecology, Obstetrics and Reproductive Medicine University Medical School of Saarland Saarbrücken Germany

3. Roche Products Welwyn Garden City UK

4. Medizinische Hochschule Hannover Hanover Germany

5. Center for Medical Statistics, Informatics, and Intelligent Systems Medical University of Vienna Vienna Austria

6. Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim am Rhein Germany

7. Norwegian Medicine Agency Oslo Norway

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2120

Reference44 articles.

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

2. BBS Spring Seminar on External Controls.https://roche.jiveon.com/thread/53799; 2019.

3. White paper by the EFPIA Clinical Trial Design Taskforce Innovation in Clinical Trial Design: A review of The Clinical Trial Design Landscape.

4. Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities

5. Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation

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