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

Natansh D. Modi, Ganessan Kichenadasse, Tammy C. Hoffmann, Mark Haseloff, Jessica M. Logan, Areti A. Veroniki, Rebecca L. Venchiarutti, Amelia K. Smit, Haitham Tuffaha, Harindra Jayasekara, Arkady Manning-Bennet, Erin Morton, Ross A. McKinnon, Andrew Rowland, Michael J. Sorich, Ashley M. Hopkins*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

1 Citation (Scopus)
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Abstract

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.

Original languageEnglish
Article number400
Pages (from-to)1-9
Number of pages9
JournalBMC Medicine
Volume21
Issue number1
DOIs
Publication statusPublished - Dec 2023

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