Karpen SR, White JK, Mullin AP, O’Doherty I, Hudson LD, Romero K, Sivakumaran S, Stephenson D, Turner EC, Larkindale J. Effective Data Sharing as a Conduit for Advancing Medical Product Development. Ther Innov Regul Sci. 2021 May;55(3):591-600.
Introduction: Patient-level data sharing has the potential to significantly impact the lives of patients by optimizing and improving the medical product development process. In the product development setting, successful data sharing is defined as data sharing that is actionable and facilitates decision making during the development and review of medical products. This often occurs through the creation of new product development tools or methodologies, such as novel clinical trial design and enrichment strategies, predictive pre-clinical and clinical models, clinical trial simulation tools, biomarkers, and clinical outcomes assessments, and more.
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