ISMPP West 2022

Irvine, CA

Marriott Irvine Spectrum

September 26 - September 27, 2022

Irvine, CA | Marriott Irvine Spectrum |

Learning * Engagement * Application* Development - This theme is centered on how we as a community of professionals can demonstrate leadership, at all levels to proactively drive change and create best practices.

With advancements in methods and computational power, evidence from real-world (electronic records, disease registries, wearables, etc.) and controlled randomized clinical trial (RCT) environments can be integrated to fill in evidence gaps, enhance decision-making, and advance equity in research. While real world evidence (RWE) is a broad and evolving domain, RWE-RCT integration allows for new and effective ways to generate evidence. These efforts will require thoughtful and proactive planning, execution, and reporting to implement and realize improved patient outcomes.

GordonMatthew_0221_0999.jpgParexel's Matthew Gordon, VP of RWE Strategy, will speak on "Let's Get Real: Elevating Evidence Generation through RWE-RCT Integration" on Tuesday, September 27 at 10:00am.  This session will provide an overview and value proposition for RWE-RCT integration for evidence generation.  Case studies will be presented to illustrate how to create and implement in large company and small company settings to drive evidence generation. Participants will learn about current industry standards, regulatory guidance and reporting guidelines (STaRT template) for RWE planning and reporting. Emphasis will be placed on understanding the role of publication professionals in driving the incorporation of RWE-RCT as part of the overall evidence generation and publication strategy.

 

  • Lead your organization in the integration of RWE/RCT evidence generation as part of your publication strategy and communication strategy (opportunities and challenges)
  • Equity can be advanced through integration of RWE/RCT, as clinical trials have historically not been representative of the general population compared to RWD
  • Advocate for adoption of RWE based on case studies and regulatory pathways as delineated by the FDA, EMA, and Health Canada
  • Drive robust integrated RWE/RCT study design and clear communication of methods for the purposes of transparency and reproducibility, to avoid misinterpretation and bias

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