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 Lessler, Eric T. Lofgren, Ira M. Longini, Jukka-Pekka Onnela, Berk Özler, George R. Seage, Thomas A. Smith, Alessandro Vespignani, Emilia Vynnycky and Marc Lipsitch


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.

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