An Uncommon Expert

Jeff Trotter, MBA

Senior Vice President, Scientific Solutions, Real World Evidence

Jeff Trotter, Senior Vice President for Worldwide Evidence™ , supports customers with the critical transition from clinical development to commercialization. With more than three decades of experience and an MBA from Northwestern University, Jeff brings a pioneering spirit to the evolving health economics and outcomes research community. As an accomplished speaker and author with over 50 published articles and research papers, he prioritizes personalized customer service, practical guidance based in experience, and candid communications grounded in mutual respect and cultural sensitivity through his role at Worldwide.

A Message from Jeff Trotter, MBA:

As the clinical research industry is going through this time of disruption and new opportunities, we are witnessing a shift in the potential for real-world evidence (RWE) to support drug development and commercialization. Here are a few of the trends I see in the RWE space:

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Real-world evidence is expanding from its traditional application as a post-approval resource to that of a supplemental data source alongside randomized clinical trials. Used earlier in the drug development timeline, RWE can be instrumental in patient and site recruitment, in support of protocol optimization, and potentially in the development of a simulated control arm. Importantly, early creation and implementation of a real-world evidence plan of action can improve the essential peri- and post-approval documentation and communication of clinical, economic, and humanistic effectiveness to key industry stakeholders.

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COVID-19 has contributed to a shift in standard of care, accelerating technology-based trends. Not only are sponsors interested in better understanding the “new normal” in terms of standards of care but also everyone wants to determine the impact of these shifts on treatments and patient outcomes. Evaluations of the impact of novel therapies across most disease states now must be undertaken within the context of the new baseline standard of care.

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Technological advancements are enabling existing retrospective data to augment prospective de novo research in real-world evidence. While increased access to high- quality data is providing us with new and cost-efficient mechanisms for RWE, and in some cases, of sufficient rigor to support regulatory approval, prospective observational studies and registries remain the gold standard for developing both robust evidence and stakeholder engagement.

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SPEAKING TOPICS INCLUDE:

• Evidence strategy and planning
• Health economics and outcomes research
• Patient registries and observational studies

ABOUT JEFF TROTTER, MBA

Jeff Trotter was named Senior Vice President, Worldwide Evidence™ following the company’s acquisition of Continuum Clinical’s Late Stage (Observational Research and HEOR) division that completed in January 2018. Jeff served as president of Continuum since 2014, supporting clients with the critical transition from clinical development to commercialization through research excellence, responsible communications, and a constant focus on business strategy.

Prior to Continuum, Jeff was Executive Vice President of inVentiv Health Clinical responsible for the global late stage (clinical, outcomes, health economics, observational, safety, etc.) business and client research programs. Jeff also founded and served as president of Ovation Research Group, a leading patient registries, outcomes research, and health economics firm for more than 16 years before it was acquired by ICON in July 2006.

As an entrepreneur, researcher, consultant, and innovator with more than 30 years of experience, Jeff has been a pioneer in the evolving health economics and outcomes research community and is an industry leader in the design and implementation of patient registries and observational studies. He has spoken widely in front of varied industry audiences and 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.

He holds an accounting degree (B.S.) from University of Illinois at Urbana-Champaign and a masters in management (M.B.A.) with concentrations in finance, marketing, organizational behavior, and health service management from Northwestern University – Kellogg School of Management.

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