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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

Hosted Event/Non-CE: Case Study Spotlight hosted by Purpose Life Sciences: RWE Integration by Design: An Essential Component of Early RCT Design

Session Chair(s)

  Sponsored Sessions

Sponsored Sessions

United States

Real-world data (RWD) and real-world evidence (RWE) often find their place in clinical development toward its conclusion. Results derived from them are often reserved for medical affairs, market access, or to bolster existing pre-planned clinical trials. However, this approach can create significant challenges, hindering the potential utility of RWE due to trial designs and protocols that may not align well with generating fit-for-purpose RWD. Today, there is growing momentum from regulators and scientists to shift towards a systematic integration of RWE during the initial trial design phase.

This presentation sheds light on the barriers that traditionally separate randomized clinical trials (RCTs) and RWE, highlighting the need for a more blended approach. Emerging concepts such as externally controlled trials and innovative designs like cohort multiple randomized controlled trials or trials within-cohorts are gaining traction as effective means to capture novel patient insights. By exploring the convergence of these diverse methodologies, we can uncover more meaningful and comprehensive insights than what each can achieve independently.

Learning Objective :
  • Describe how current clinical trial design strategies and frameworks create barriers to RWE inclusion
  • Explain the mechanics of blended trial and RWE approaches, and their potential to amplify the value of trial results
  • Explore the operational and pragmatic implications for adopting integrated RWE and trial strategies


Dallas  Hodgson


Dallas Hodgson

Purpose Life Sciences, Canada

Vice President, Innovation Partnerships

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