Previously submitted to: JMIR Medical Informatics (no longer under consideration since Apr 16, 2021)
Date Submitted: Jan 5, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Future ready real world data for healthcare optimisation and evidence-based decision making
ABSTRACT
The life science industry is facing increasing pressure to demonstrate value of its innovations beyond product safety and efficacy studied in traditional clinical trials, which is hampered by limited access to readily available, well-characterised patient data generated during routine clinical care. The purpose of this paper is to describe how future structure, content, and availability of healthcare data can improve patient access to new therapeutics and industry’s possible role in overcoming the challenges around data characterisation, governance and transparency in order to fully leverage the value of real world evidence (RWE) for patients, doctors, health systems and other stakeholders.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.