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Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis

Author

Listed:
  • Jörg Mahlich

    (Health Economics and Outcomes Research, Janssen, Pharmaceutical Companies of Johnson & Johnson
    University of Düsseldorf)

  • Arne Bartol

    (Government Affairs, Janssen, Pharmaceutical Companies of Johnson & Johnson)

  • Srirangan Dheban

    (Health Economics and Outcomes Research, Janssen, Pharmaceutical Companies of Johnson & Johnson)

Abstract

Aim The productivity of pharmaceutical research and development (R&D) investments is declining due to high failure rates in clinical research. Recently, the US Food and Drug Administration (FDA) acknowledged that adaptive designs can make drug development more efficient and less costly. Our objective is to simulate cost-saving effects and estimate the impact on global R&D expenditures as well as possible outcomes measured in life-years gained. Methods Based on published drug-development cost data we calculate potential cost savings derived from variations in clinical success rates that result from employing adaptive trial designs. In a subsequent step we estimate how those cost changes affect global R&D expenditures and outcomes. Results Our calculations indicate that an adaptive trial design with the potential to increase success rates of clinical trials by 4 percentage points could lower development costs for a new drug from 2.6 to 2.2bn USD. On a global scale, this cost reduction would free up an additional 4.2bn USD for investment into pharmaceutical R&D to bring about drug innovations that in turn would be capable of generating up to 3.5 million life-years. Conclusion New clinical trial designs are crucial to improving productivity within the pharmaceutical industry and to fostering a sustainable health-care system.

Suggested Citation

  • Jörg Mahlich & Arne Bartol & Srirangan Dheban, 2021. "Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis," Health Economics Review, Springer, vol. 11(1), pages 1-10, December.
    • Handle: RePEc:spr:hecrev:v:11:y:2021:i:1:d:10.1186_s13561-021-00302-6
    DOI: 10.1186/s13561-021-00302-6
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    References listed on IDEAS

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    1. Hartwig, Jochen, 2008. "What drives health care expenditure?--Baumol's model of 'unbalanced growth' revisited," Journal of Health Economics, Elsevier, vol. 27(3), pages 603-623, May.
    2. Fabio Pammolli & Massimo Riccaboni & Laura Magazzini, 2010. "The productivity crisis in pharmaceutical R&D," Working Papers 06/2010, University of Verona, Department of Economics.
    3. Stephan Eger & Jörg Mahlich, 2014. "Pharmaceutical regulation in Europe and its impact on corporate R&D," Health Economics Review, Springer, vol. 4(1), pages 1-9, December.
    4. Jorge Mestre-Ferrandiz;Jon Sussex;Adrian Towse, 2012. "The R&D Cost of a New Medicine," Monograph 000135, Office of Health Economics.
    5. Wiggins, Steven N, 1981. "Product Quality Regulation and New Drug Introductions: Some New Evidence from the 1970s," The Review of Economics and Statistics, MIT Press, vol. 63(4), pages 615-619, November.
    6. Daron Acemoglu & David Autor & David Dorn & Gordon H. Hanson & Brendan Price, 2016. "Import Competition and the Great US Employment Sag of the 2000s," Journal of Labor Economics, University of Chicago Press, vol. 34(S1), pages 141-198.
    7. Olson, Mary K., 2004. "Are novel drugs more risky for patients than less novel drugs?," Journal of Health Economics, Elsevier, vol. 23(6), pages 1135-1158, November.
    8. Blind, Knut & Petersen, Sören S. & Riillo, Cesare A.F., 2017. "The impact of standards and regulation on innovation in uncertain markets," Research Policy, Elsevier, vol. 46(1), pages 249-264.
    9. Peltzman, Sam, 1973. "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments," Journal of Political Economy, University of Chicago Press, vol. 81(5), pages 1049-1091, Sept.-Oct.
    10. John Vernon, 2003. "The relationship between price regulation and pharmaceutical profit margins," Applied Economics Letters, Taylor & Francis Journals, vol. 10(8), pages 467-470.
    11. Jörg Mahlich & B. Burcin Yurtoglu, 2019. "Returns on different types of investment in the global pharmaceutical industry," Managerial and Decision Economics, John Wiley & Sons, Ltd., vol. 40(1), pages 16-36, January.
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    1. Chris Sampson’s journal round-up for 8th March 2021
      by Chris Sampson in The Academic Health Economists' Blog on 2021-03-08 12:00:01

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