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Session 7: Real Word Evidence: How Can it be Used to Support Regulatory Decision-Making
Session Chair(s)
Sonia Viejobueno, LLM
US and Latin America Policy Lead, Global Regulatory Policy and Intelligence
Johnson & Johnson Innovative Medicine, Argentina
Real world data is the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real world evidence is the clinical evidence regarding the usage and potential benefits, or risks of a medical product derived from analysis of RWD. RWD and RWE are playing an increasing role in healthcare decisions.
Historically used for post-market safety monitoring, regulatory agencies and medical product sponsors are increasingly interested in incorporating RWE into their programs to support clinical trial design (eg. large simple trials, pragmatic clinical trials) and observational studies in order to generate innovative, new treatment approaches.
However, RWE still raises many new technical and policy issues. For example: when is the quality of the data sufficient or acceptable for regulatory assessment? What real-world endpoints are acceptable? How can sponsors adequately minimize bias to measure the true effect of the therapy?
In this session, we will analyze existing RWE regulatory programs, explore the potential for using RWE in medical product decision-making to incorporate patient experience as well as earlier access to innovative medicines for patients, and discuss how this can be taken forward in our region with engagement from all key stakeholders.
Learning Objective :
At the completion of this session, participants should be able to :
- Understand what RWE means and why it has become increasingly important in the context of evolving evidentiary standards for regulatory decision-making
- Obtain greater understanding of existing RWE regulatory programs benefits and limitations by discussing different data sources that may represent RWD and contribute to RWE medical product evaluations
Speaker(s)
Speaker
David Martin, MD, MPH
Moderna, United States
Vice President, Global Head RWE
Speaker
Kourtney J. Davis, PhD, MPH
Janssen, United States
Senior Director and Head, Therapy Area Matrix, Global Epidemiology
Speaker
Jaclyn Bosco, PhD, MPH, FISPE
IQVIA, United States
Vice President and Global Head of Epidemiology