title: Optimizing the leveraging of real-world data to improve the development and use of medicines.
abstract: Health research, including health outcomes and comparative effectiveness research, is on the cusp of a golden era of access to digitized real-world data, catalyzed by the adoption of electronic health records and the integration of clinical and biological information with other data. This era promises more robust insights into what works in health care. Several barriers, however, will need to be addressed if the full potential of these new data are fully realized; these will involve both policy solutions and stakeholder cooperation. Although a number of these issues have been widely discussed, we focus on the one we believe is the most important-the facilitation of greater openness among public and private stakeholders to collaboration, connecting information and data sharing, with the goal of making robust and complete data accessible to all researchers. In this way, we can better understand the consequences of health care delivery, improve the effectiveness and efficiency of health care systems, and develop advancements in health technologies. Early real-world data initiatives illustrate both potential and the need for future progress, as well as the essential role of collaboration and data sharing. Health policies critical to progress will include those that promote open source data standards, expand access to the data, increase data capture and connectivity, and facilitate communication of findings.
authors.affiliation: Pfizer, Inc, New York, NY, USA. Electronic address: marc.berger@pfizer.com.
authors.forename: Marc L
authors.initials: ML
authors.lastname: Berger
authors.affiliation: Pfizer, Inc, New York, NY, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Lipset
authors.affiliation: Pfizer, Inc, New York, NY, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: Gutteridge
authors.affiliation: Pfizer, Inc, New York, NY, USA.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Axelsen
authors.affiliation: Pfizer, Inc, New York, NY, USA.
authors.forename: Prasun
authors.initials: P
authors.lastname: Subedi
authors.affiliation: Columbia University, New York, NY, USA.
authors.forename: David
authors.initials: D
authors.lastname: Madigan
mesh_terms: D057186:Comparative Effectiveness Research / Q000379:methods* / Q000639:trends; D003695:Delivery of Health Care / Q000379:methods* / Q000639:trends; D006291:Health Policy / Q000639:trends; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D012108:Research Personnel / Q000639:trends
chemical_list: D004364:Pharmaceutical Preparations
keywords: big data; data access; health policy; health research; real-world data