The future of safety science is happening now: The modernization of the benefit-risk paradigm

Pharmacoepidemiol Drug Saf. 2017 Aug;26(8):869-874. doi: 10.1002/pds.4241. Epub 2017 Jun 8.


The future of safety science is happening now and has the potential to improve patient outcomes through an evolving approach to benefit-risk assessment. Three building blocks for the future of safety science, cognitive and behavioral systems, medical assessment, and data science, individually and collaboratively advance and modernize the benefit-risk paradigm. Incorporating the patient perspective and patient experiences will help identify tools that are useful in real-world practice. Medical assessment teams will bring together the study of toxicity and toxicogenomics, biomarkers, and special populations to personalize the benefit-risk profile. Personalized benefit-risk profiles for patients will help improve outcomes. Data science and related quantitative sciences such as safety statistics, database integration, technology, and epidemiology will provide new approaches and tools for analysis of safety data as well as more rapid access to insights that benefit patients.

Publication types

  • Review

MeSH terms

  • Behavioral Sciences / standards
  • Behavioral Sciences / trends*
  • Cognitive Science / standards
  • Cognitive Science / trends*
  • Forecasting
  • Humans
  • Patient Safety* / standards
  • Pharmacovigilance*
  • Risk Assessment / standards
  • Risk Assessment / trends