Democratizing data at Novartis through clinical trial data access. Issue 6 (June 2022)

• Record Type: Journal Article
• Authors: Eichler, Gabriel S.; Imbert, Georges; Branson, Janice; Balibey, Rene; Laramie, Jason M.
• Is Part Of: Drug discovery today. Volume 27:Issue 6(2022)
• Page Start: 1533
• Page End: 1537
• Publication Date: 2022-06
• Subjects: Data access -- Clinical trials -- Data lake -- Digital transformation -- Data Democratization; Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2022.02.019
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: Novartis formed a program to make access and reuse of (R&D) data routine. Many hurdles frequently prevent streamlined and scaled use of clinical trial data. We owe patients to protect their data while maximize its use to advance medicine. A blueprint for companies to accelerate their progress in a patient-first manner. A majority of internal requests for clinical data, can be automatically approved. Abstract: Enabling broad access and usage of clinical trial data within biopharmaceutical companies has historically been impeded by technical, cultural, and policy hurdles. Novartis has attempted to address this comprehensively through a program called data42; here, we explore how a diverse set of enterprise-wide stakeholders formulated a risk-based data access approach to streamline access to anonymized clinical trial data and vastly improved its use by authorized research and development (R&D) associates within the company. The result is that most Novartis clinical trial data requests, from internal associates, can now be automatically approved. The process of developing this framework and its impact on Novartis and the broader industry are explored and discussed.