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    Economics of new oncology drug development.

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    Date
    2007-01-10
    Authors
    DiMasi, Joseph A
    Grabowski, Henry G
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    Abstract
    PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.
    Type
    Journal article
    Subject
    Antineoplastic Agents
    Drug Approval
    Drug Costs
    Drug Design
    Drug Industry
    Economics, Pharmaceutical
    Humans
    Neoplasms
    Permalink
    https://hdl.handle.net/10161/6612
    Published Version (Please cite this version)
    10.1200/JCO.2006.09.0803
    Publication Info
    DiMasi, Joseph A; & Grabowski, Henry G (2007). Economics of new oncology drug development. J Clin Oncol, 25(2). pp. 209-216. 10.1200/JCO.2006.09.0803. Retrieved from https://hdl.handle.net/10161/6612.
    This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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    Scholars@Duke

    Grabowski

    Henry G. Grabowski

    Professor Emeritus of Economics
    Professor Grabowski specializes in the investigation of economics in the pharmaceutical industry, government regulation of business, and the economics of innovation. His specific interests within these fields include intellectual property and generic competition issues, the effects of government policy actions, and the costs and returns to pharmaceutical R&D. He has been publishing research papers for over four decades, from his earlier work, “The Effects of Regulatory Policy on the Incentives
    Open Access

    Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

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