01.002 RWE GS May 2022 E 26-05-2022

Industry leaders praise real-world evidence (RWE) in COVID-19 pandemic

Scott Gottlieb, Former Commissioner of the FDA has pointed out several ways RWE was utilised during the COVID-19 pandemic:
  • Post-market data collection: RWE will provide flexibility for post-market safety and effectiveness data collection on the initial cohorts of patients
  • Regulatory decision making: RWE has been an important factor in making decisions about patient care during the pandemic on the basis of large datasets
  • Clinical development:“You’ve seen a lot of amendments to [clinical trial] protocols where there have been missing data—such as from patients lost to follow-up—and sponsors have been able to use RWE to augment the datasets that were already being accrued, to compensate for some of the complexities that were created by COVID such as not being able to bring patients back onsite for follow-up,”
  • Accelerated clinical learnings: A lot of learnings and improvements in clinical care have come from large practical datasets and the practical applications of clinical care in a real-world setting (i.e. taking care of patients with COVID-19 during a public health emergency)
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