Enhancing Clinical Cancer Research Through Sharing of Data and Biospecimens

作者：Hans Wildiers, Virginie Sarah Adam, Séamus O’Reilly, Josephine Van Cauwenberge, Amal Arahmani, Carlos L. Arteaga, Philippe Lucien Bedard, Judith M. Bliss, Panayota Boussis, Etienne G.C. Brain, Marc E Buyse, Carmela Caballero, David Cameron, Fátima Cardoso, Eva Carrasco, Ana Casas, Boon Hui Chua, Giuseppe Curigliano, Angela DeMichele, Laura Esserman, Giuseppe Floris, Matthew Philip Goetz, Theodora Goulioti, Benjamin Haibe‐Kains, Christine Hodgdon, Michail Ignatiadis, Marleen Kok, Denis A. Lacombe, Barbro Kristina Linderholm, Sherene Loi, Christopher J. Lord, Mairead MacKenzie, Julia Maués, Lydie Meheus, Judy Needham, Patrick Neven, Heather Anne Parsons, Martine J Piccart, Lajos Pusztai, E. Razis, Shigehira Saji, Eva Schumacher-Wulf, Gabe S. Sonke, Tania Spanic, Ian F. Tannock, Andrew N.J. Tutt, Ander Urruticoechea, Laura van ‘t Veer, Inês Vaz-Luís, Gustavo Werutsky, Douglas Yee, Khalil Zaman, Christine Desmedt · 发表于：JAMA Oncology · 年份：2025 · DOI：10.1001/jamaoncol.2025.5376 · 被引用次数：7 · 研究领域：Cancer Genomics and Diagnostics、Ethics in Clinical Research、Biomedical Ethics and Regulation

Importance: Molecular analyses of biospecimens collected from study participants are essential for identifying biomarkers that can tailor treatments to specific subsets of patients who are most likely to benefit. Sharing of data and biospecimens from clinical trials enables personalized, patient-centric use of cancer therapies and accelerates the development of new treatments. Objective: To describe obstacles to sharing data and biospecimens and to propose strategies to enhance access and collaboration. Evidence Review: This is a Special Communication authored by 53 academic investigators and patient representatives from the breast cancer community with extensive experience in conducting clinical and translational research. The article also evaluates the impact of biomarker research on specifying responsive subpopulations in the 29 registrational clinical trials that have led to approval of a new drug for treatment of breast cancer between 2017 and 2024. Findings: Clinical trial participants are increasingly asked to provide tissue and/or body fluid biospecimens for biomarker research that is typically controlled by the sponsoring pharmaceutical company, but published biomarker studies are rare. Among 29 breast cancer registrational studies reported in the past 8 years, none resulted in biomarker research that restricted a drug's approved indication. Herein, strategies to maximize the value of clinical data and biospecimens contributed by participants are proposed, thereby su...