Paul Beninger1, James Connelly2, Chandrasekhar Natarajan3. 1. Public Health & Community Medicine, Tufts University School of Medicine, Boston, Massachusetts. Electronic address: paul.beninger@tufts.edu. 2. ClinDataPro, LLC, Waltham, Massachusetts. 3. ViNa Pharma, Consultants, LLC, Cambridge, Massachusetts.
Abstract
OBJECTIVE: This Commentary shows that the present emphasis on the sharing of data from clinical trials can be extended to the entire pharmaceutical enterprise. METHODS: The authors constructed a Data Sharing Dashboard that shows the relationship between all of the life-cycle domains of the pharmaceutical enterprise from discovery to obsolescence and the domain-bridging disciplines, such as target credentialing, structure-activity relationships, and exposure-effect relationships. FINDINGS: The published literature encompassing the pharmaceutical enterprise is expansive, covering the major domains of discovery, translation, clinical development, and post-marketing outcomes research, all of which have even larger, though generally inaccessible, troves of legacy data bases. Notable exceptions include the fields of genomics and bioinformatics. IMPLICATIONS: We have the opportunity to broaden the present momentum of interest in data sharing to the entire pharmaceutical enterprise, beginning with discovery and extending into health technology assessment and post-patent expiry generic use with the plan of integrating new levels and disciplines of knowledge and with the ultimate goal of improving the care of our patients.
OBJECTIVE: This Commentary shows that the present emphasis on the sharing of data from clinical trials can be extended to the entire pharmaceutical enterprise. METHODS: The authors constructed a Data Sharing Dashboard that shows the relationship between all of the life-cycle domains of the pharmaceutical enterprise from discovery to obsolescence and the domain-bridging disciplines, such as target credentialing, structure-activity relationships, and exposure-effect relationships. FINDINGS: The published literature encompassing the pharmaceutical enterprise is expansive, covering the major domains of discovery, translation, clinical development, and post-marketing outcomes research, all of which have even larger, though generally inaccessible, troves of legacy data bases. Notable exceptions include the fields of genomics and bioinformatics. IMPLICATIONS: We have the opportunity to broaden the present momentum of interest in data sharing to the entire pharmaceutical enterprise, beginning with discovery and extending into health technology assessment and post-patent expiry generic use with the plan of integrating new levels and disciplines of knowledge and with the ultimate goal of improving the care of our patients.
Authors: Kevin Nam; Kay Larholt; Gigi Hirsch; Paul Beninger; David Fritsche; Diane Shoda; John Ferguson; Florence T Bourgeois; Donna Palmer; Karen Katz; Matt W Courtney Journal: Ther Innov Regul Sci Date: 2020-10-28 Impact factor: 1.778