College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
Flinders Centre for Innovation in Cancer, Department of Medical Oncology, Flinders Medical Centre, Adelaide, SA, Australia.
BMC Med. 2023 Oct 23;21(1):400. doi: 10.1186/s12916-023-03113-0.
Data sharing is essential for promoting scientific discoveries and informed decision-making in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote scientific advancements. However, despite these commitments, recent investigations indicate significant scope for improvements in data sharing by the pharmaceutical industry. Drawing on a decade of literature and policy developments, this article presents perspectives from a multidisciplinary team of researchers, clinicians, and consumers. The focus is on policy and process updates to the PhRMA/EFPIA 2013 data sharing commitments, aiming to enhance the sharing and accessibility of participant-level data, clinical study reports, protocols, statistical analysis plans, lay summaries, and result publications from pharmaceutical industry-sponsored trials. The proposed updates provide clear recommendations regarding which data should be shared, when it should be shared, and under what conditions. The suggested improvements aim to develop a data sharing ecosystem that supports science and patient-centred care. Good data sharing principles require resources, time, and commitment. Notwithstanding these challenges, enhancing data sharing is necessary for efficient resource utilization, increased scientific collaboration, and better decision-making for patients and healthcare professionals.
数据共享对于促进临床医学中的科学发现和明智决策至关重要。2013 年,PhRMA/EFPIA 认识到数据共享的重要性,并支持加强临床试验数据透明度和促进科学进步的倡议。然而,尽管有这些承诺,最近的调查表明制药行业在数据共享方面仍有很大的改进空间。本文借鉴了十年来的文献和政策发展,展示了来自多学科研究团队、临床医生和消费者的观点。重点是更新 PhRMA/EFPIA 2013 年数据共享承诺的政策和流程,旨在增强制药业赞助试验的参与者水平数据、临床研究报告、方案、统计分析计划、通俗摘要和结果出版物的共享和可及性。拟议的更新就应该共享哪些数据、何时共享以及在什么条件下共享提供了明确的建议。这些改进旨在开发一个支持科学和以患者为中心的护理的数据共享生态系统。良好的数据共享原则需要资源、时间和承诺。尽管存在这些挑战,但加强数据共享对于提高资源利用效率、增加科学合作以及为患者和医疗保健专业人员做出更好的决策是必要的。