Simulations for designing and interpreting intervention trials in infectious diseases

M. Elizabeth Halloran, Kari Auranen, Sarah Baird, Nicole E. Basta, Steven E. Bellan, Ron Brookmeyer, Ben S. Cooper, Victor DeGruttola, James P. Hughes, Justin T Lessler, Eric T. Lofgren, Ira M. Longini, Jukka Pekka Onnela, Berk Özler, George R. Seage, Thomas A. Smith, Alessandro Vespignani, Emilia Vynnycky, Marc Lipsitch

Research output: Contribution to journalArticle

Abstract

Background: Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. Discussion: Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. Conclusion: Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.

Original languageEnglish (US)
Article number223
JournalBMC Medicine
Volume15
Issue number1
DOIs
Publication statusPublished - Dec 29 2017

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Keywords

  • Clinical trial design
  • Infectious diseases
  • Mathematical modeling
  • Simulations
  • Vaccine

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Halloran, M. E., Auranen, K., Baird, S., Basta, N. E., Bellan, S. E., Brookmeyer, R., ... Lipsitch, M. (2017). Simulations for designing and interpreting intervention trials in infectious diseases. BMC Medicine, 15(1), [223]. https://doi.org/10.1186/s12916-017-0985-3