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A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates

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Listed:
  • Donald A. Berry
  • Scott Berry
  • Peter Hale
  • Leah Isakov
  • Andrew W. Lo
  • Kien Wei Siah
  • Chi Heem Wong

Abstract

We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomized clinical trials and adaptive and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 504 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.

Suggested Citation

  • Donald A. Berry & Scott Berry & Peter Hale & Leah Isakov & Andrew W. Lo & Kien Wei Siah & Chi Heem Wong, 2020. "A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates," NBER Working Papers 27882, National Bureau of Economic Research, Inc.
    • Handle: RePEc:nbr:nberwo:27882
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    References listed on IDEAS

    as
    1. Isakov, Leah & Lo, Andrew W. & Montazerhodjat, Vahid, 2019. "Is the FDA too conservative or too aggressive?: A Bayesian decision analysis of clinical trial design," Journal of Econometrics, Elsevier, vol. 211(1), pages 117-136.
    2. Fernández-Villaverde, Jesús & Jones, Charles I., 2022. "Estimating and simulating a SIRD Model of COVID-19 for many countries, states, and cities," Journal of Economic Dynamics and Control, Elsevier, vol. 140(C).
    3. Andrew W. Lo & Kien Wei Siah & Chi Heem Wong, 2020. "Estimating Probabilities of Success of Vaccine and Other Anti-Infective Therapeutic Development Programs," NBER Working Papers 27176, National Bureau of Economic Research, Inc.
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    Cited by:

    1. Rachel Glennerster & Christopher M. Snyder & Brandon Joel Tan, 2023. "Calculating the Costs and Benefits of Advance Preparations for Future Pandemics," IMF Economic Review, Palgrave Macmillan;International Monetary Fund, vol. 71(3), pages 611-648, September.
    2. Jonathan Legare & Ping Yao & Victor S. Y. Lo, 2023. "A case for conducting business-to-business experiments with multi-arm multi-stage adaptive designs," Journal of Marketing Analytics, Palgrave Macmillan, vol. 11(3), pages 490-502, September.
    3. Witold Więcek, 2022. "Clinical trials for accelerating pandemic vaccines [‘A Systematic Review of Human Challenge Trials, Designs, and Safety’]," Oxford Review of Economic Policy, Oxford University Press and Oxford Review of Economic Policy Limited, vol. 38(4), pages 797-817.

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    More about this item

    JEL classification:

    • C15 - Mathematical and Quantitative Methods - - Econometric and Statistical Methods and Methodology: General - - - Statistical Simulation Methods: General
    • H12 - Public Economics - - Structure and Scope of Government - - - Crisis Management
    • H51 - Public Economics - - National Government Expenditures and Related Policies - - - Government Expenditures and Health
    • I1 - Health, Education, and Welfare - - Health
    • I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets

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