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International Clinical Trials

Top 10 Considerations When Working With RWE

Clinical trials are from Mars, realworld studies are from Venus. For clinical operations professionals, non-traditional real-world observational/ non-interventional studies can seem like they are from an entirely different planet.

However, real-world evidence (RWE) and real-world data (RWD) are becoming indispensable to clinical and commercial development for life science companies that ultimately want to see their innovations positively impact the lives of patients. It’s critical for those who support traditional clinical trials to understand the potentially unfamiliar RWE terrain. So, here are 10 concepts to illuminate the RWE landscape:

1. The Real World: Real Important, but Real Messy

Generally, products are evaluated for regulatory approval under very different conditions than those under which they are used. Controlled clinical trials are essential to our understanding of product safety and efficacy, but real-world use cases reflect a far more heterogeneous scenario.

Real-life conditions are virtually impossible to control from a research perspective. Nor would we want to, as an understanding of the effectiveness, safety, and value of a product under actual practice conditions is a primary goal of real-world research.

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About the Author

Jeff Trotter is Senior Vice President for Worldwide Evidence at Worldwide Clinical Trials. Formerly the President and Co-Founder of Continuum Clinical, Jeff’s healthcare industry career spans 30 years. A leader in the design and implementation of patient registries and observational studies, Jeff founded Ovation Research Group, an internationally known research and consulting firm, and has been in executive management with other clinical research organisations. He is a sought-after speaker who has published over 50 original articles and research papers, including a book for the American Hospital Association, The Quest for Cost-Effectiveness in Healthcare: Achieving Clinical Excellence While Controlling Cost.
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