The Bar Is High: Evaluating Fit-for-Use Oncology Real-World Data for Regulatory Decision Making-Reference-Cited by-同舟云学术

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The Bar Is High: Evaluating Fit-for-Use Oncology Real-World Data for Regulatory Decision Making

Published:2024-03 Issue:8 Volume: Page:
ISSN:2473-4276
Container-title:JCO Clinical Cancer Informatics
language:en
Short-container-title:JCO Clin Cancer Inform

Author:

Lerro Catherine C.¹,Bradley Marie C.²^ORCID,Forshee Richard A.³^ORCID,Rivera Donna R.¹^ORCID

Affiliation:

1. Oncology Center of Excellence, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD

2. Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

3. Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Publisher

American Society of Clinical Oncology (ASCO)

Link

https://ascopubs.org/doi/pdfdirect/10.1200/CCI.23.00261

Reference16 articles.

Cited by 4 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. Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence;JAMA;2024-08-05

2. When Will Real-World Data Fulfill Its Promise to Provide Timely Insights in Oncology?;JCO Clinical Cancer Informatics;2024-06

3. Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages;Diagnostics;2024-04-27

4. Characterization of Incidental Pathogenic Germline Findings Detected via ctDNA among Patients with Non-Small Cell Lung Cancer in a Predominantly Hispanic/Latinx Population;Cancers;2024-03-14

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