Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration–Approved Anticancer Drugs: A Call for Systematic Data Availability-Reference-Cited by-同舟云学术

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Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration–Approved Anticancer Drugs: A Call for Systematic Data Availability

Published:2024-06-25 Issue: Volume: Page:
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Modi Natansh D.¹^ORCID,Swain Sandra M.²,Buyse Marc³,Kuderer Nicole M.⁴,Rowland Andrew¹,Rockhold Frank W.⁵,Sorich Michael J.¹,Hopkins Ashley M.¹

Affiliation:

1. College of Medicine and Public Health, Flinders University, Adelaide, Australia

2. Georgetown Lombardi Comprehensive Cancer Center, MedStar Health, Washington, DC

3. International Drug Development Institute (IDDI) and Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Hasselt, Belgium

4. Advanced Cancer Research Group, Kirkland, WA

5. Department of Biostatistics and Bioinformatics, Duke University, Durham, NC

Abstract

Unlocking the full potential of clinical trials through comprehensive CSR and IPD sharing can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic reviews. It is time for all stakeholders to embrace transparency and advance patient-centered outcomes.

Publisher

American Society of Clinical Oncology (ASCO)

Link

https://ascopubs.org/doi/pdfdirect/10.1200/JCO.24.00539

Reference20 articles.

1. A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies

2. Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing

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