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

Modi, Natansh D; Swain, Sandra M; Buyse, Marc; Kuderer, Nicole M; Rowland, Andrew; Rockhold, Frank W; Sorich, Michael J; Hopkins, Ashley M

Modi, Natansh D; Swain, Sandra M; Buyse, Marc; Kuderer, Nicole M; Rowland, Andrew; Rockhold, Frank W; Sorich, Michael J; Hopkins, Ashley M.

Afiliação

Modi ND; College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Swain SM; Georgetown Lombardi Comprehensive Cancer Center, MedStar Health, Washington, DC.
Buyse M; International Drug Development Institute (IDDI) and Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Hasselt, Belgium.
Kuderer NM; Advanced Cancer Research Group, Kirkland, WA.
Rowland A; College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Rockhold FW; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.
Sorich MJ; College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Hopkins AM; College of Medicine and Public Health, Flinders University, Adelaide, Australia.

J Clin Oncol ; : JCO2400539, 2024 Jun 25.

Article em En | MEDLINE | ID: mdl-38917375

ABSTRACT

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.

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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article

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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article