title: Clinical evidence inputs to comparative effectiveness research could impact the development of novel treatments.
abstract: OBJECTIVE
  This study aims to analyze the impacts of a range of clinical evidence generation scenarios associated with comparative effectiveness research (CER) on pharmaceutical innovation.
  
  
  METHODS
  We used the Global Pharmaceutical Policy Model to project the effect of changes in pharmaceutical producer costs, revenues and timings on drug innovation and health for the age 55+ populations in the USA and Europe through year 2060 using three clinical scenarios.
  
  
  RESULTS
  Changes in producer incentives from widespread CER evidence generation and use had varied but often large predicted impacts on simulated outcomes in 2060. Effect on the number of new drug introductions ranged from a 81.1% reduction to a 45.5% increase, and the effect on population-level life expectancy ranged from a 15.6% reduction to a 11.4% increase compared to baseline estimates.
  
  
  CONCLUSIONS
  The uncertainty surrounding the consequences of increased clinical evidence generation and use on innovation calls for a carefully measured approach to CER implementation, balancing near-term benefits to spending and health with long-term implications for innovation.
authors.affiliation: Precision Health Economics, Los Angeles, CA, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Eber
authors.affiliation: University of Southern California, Los Angeles, CA, USA.
authors.forename: Dana P
authors.initials: DP
authors.lastname: Goldman
authors.affiliation: University of Southern California, Los Angeles, CA, USA.
authors.forename: Darius N
authors.initials: DN
authors.lastname: Lakdawalla
authors.affiliation: University of Chicago, Chicago, IL, USA.
authors.forename: Tomas J
authors.initials: TJ
authors.lastname: Philipson
authors.affiliation: National Pharmaceutical Council, Washington, DC, USA.
authors.forename: Daryl
authors.initials: D
authors.lastname: Pritchard
authors.affiliation: University of Southern California, Los Angeles, CA, USA.
authors.forename: Marco
authors.initials: M
authors.lastname: Huesch
authors.affiliation: Precision Health Economics, Los Angeles, CA, USA.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Summers
authors.affiliation: Precision Health Economics, Los Angeles, CA, USA.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Linthicum
authors.affiliation: Precision Health Economics, Los Angeles, CA, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Sullivan
authors.affiliation: National Pharmaceutical Council, Washington, DC, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Dubois
keywords: Global Pharmaceutical Policy Model; clinical trials; comparative effectiveness research; head-to-head trials; innovation; personalized medicine; population health; trial size