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Pharmaceutical research and development: A key informant assessment of whether an 'open-science' model could improve clinical research in terms of quality and efficiency

Posted on:2014-05-06Degree:Dr.P.HType:Dissertation
University:The University of North Carolina at Chapel HillCandidate:King, Timothy D. NFull Text:PDF
GTID:1459390008951815Subject:Health Sciences
Abstract/Summary:
The average cost to develop each new pharmaceutical drug is approximately ;Spending over ;One concept proposed to improve R&D; efficiency and quality is to make the process more transparent and collaborative where researchers, even those from competing pharmaceutical companies, could more freely share information on their research designs, processes and outcomes. This concept, "open-science" R&D; (OSRD), differs from traditional R&D; approaches that typically are more secretive and less collaborative.;To explore whether OSRD could be a viable and beneficial alternative to current pharmaceutical R&D; practices, key informants from academia, industry, and regulatory agencies were interviewed using a qualitative, semi-structured questionnaire. While the key informants were concerned that for-profit pharmaceutical companies would not voluntarily embrace OSRD, the results also revealed that, 1) OSRD may be more efficient and therefore better in terms of R&D; costs, 2) many OSRD-type activities are already in place, 3) more transparency is probably inevitable, and 4) senior leaders, including those in industry, are open to exploring opportunities for broad transparency and collaboration such as those envisioned in OSRD.
Keywords/Search Tags:Pharmaceutical, OSRD, Key
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