A Comparison of 7 Oncology External Control Arm Case Studies: Critiques From Regulatory and Health Technology Assessment Agencies-Reference-Cited by-同舟云学术

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A Comparison of 7 Oncology External Control Arm Case Studies: Critiques From Regulatory and Health Technology Assessment Agencies

Published:2022-12 Issue:12 Volume:25 Page:1967-1976
ISSN:1098-3015
Container-title:Value in Health
language:en
Short-container-title:Value in Health

Author:

Jaksa Ashley,Louder Anthony,Maksymiuk Christina,Vondeling Gerard T.,Martin Laura,Gatto Nicolle,Richards Eric,Yver Antoine,Rosenlund Mats

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference11 articles.

1. A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review;Beaver;JAMA Oncol,2018

2. A review of NICE appraisals of pharmaceuticals 2000-2016 found variation in establishing comparative clinical effectiveness;Anderson;J Clin Epidemiol,2019

3. Synthetic and external controls in clinical trials – a primer for researchers;Thorlund;Clin Epidemiol,2020

4. Methods for external control groups for single arm trials or long-term uncontrolled extensions to randomized clinical trials;Seeger;Pharmacoepidemiol Drug Saf,2020

5. Real-world evidence to support regulatory decision-making for medicines: considerations for external control arms;Burcu;Pharmacoepidemiol Drug Saf,2020

Cited by 22 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Cancer registry as external control data for regulatory submission in Japan;ESMO Real World Data and Digital Oncology;2024-12

2. Real‐world evidence to support regulatory submissions: A landscape review and assessment of use cases;Clinical and Translational Science;2024-08

3. Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs;Clinical Pharmacology & Therapeutics;2024-07-02

4. Examining external control arms in oncology: A scoping review of applications to date;Cancer Medicine;2024-07

5. Augmenting external control arms using Bayesian borrowing: a case study in first-line non-small cell lung cancer;Journal of Comparative Effectiveness Research;2024-05

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