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Decision-Making in Sequential Adaptive Clinical Trials, with Implications for Drug Misclassification and Resource Allocation

  • Alba C. Rojas-CordovaEmail author
  • Ebru K. Bish
  • Niyousha Hosseinichimeh
Chapter
  • 169 Downloads
Part of the Women in Engineering and Science book series (WES)

Abstract

Sequential adaptive clinical trials for new drugs and treatment options represent flexible designs that allow for an earlier-than-planned trial termination, due to established benefit or futility. This novel and innovative approach to drug testing has the potential to accelerate patient access to new therapies and reduce expenditures on drug development. However, this approach also complicates the resource allocation (patient enrollment) and trial termination decisions, which, in turn, impact the probability of misclassification and time-to-market for the new drug, as well as the firm’s profit. In this chapter, we review current practices and the state of the art of sequential designs for adaptive clinical trials with binary response, present novel mathematical models that we have developed to address the resource allocation and trial termination decisions in these trials, and discuss their implications on public policy. We conclude with a discussion of the challenges and the opportunities for future research in this area.

Notes

Acknowledgements

We would like to thank Mr. Keith Gardner, Senior Director of Decision Science at AstraZeneca Pharmaceuticals, for many valuable discussions that improved our understanding of the drug R&D process. This research was supported in part by the Seth Bonder Foundation.

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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Alba C. Rojas-Cordova
    • 1
    Email author
  • Ebru K. Bish
    • 2
  • Niyousha Hosseinichimeh
    • 2
  1. 1.Department of EMISSouthern Methodist UniversityDallasUSA
  2. 2.Grado Department of Industrial and Systems EngineeringVirginia TechBlacksburgUSA

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