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Making Evidence at Launch More Real-World: Pragmatic Trials, Current Developments and Operational Challenges
Session Chair(s)
Pieter Stolk, PharmD, PhD
Project Manager
University Medical Centre Utrecht, Netherlands
Pragmatic relative effectiveness (RE) trials are essential to compare treatment strategies. Designing and executing such real-world trials pre-launch is challenging. In this workshop, we will assess pragmatic study design options, their operational feasibility and methodological implications.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Walter E. Washington Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.
Learning Objective : Recognize different design options for pre-launch pragmatic relative effectiveness (RE) trials that aim to better meet HTA needs; Identify operational challenges in setting up and conducting pragmatic RE trials; Assess the impact of these design options and their operational challenges on study validity, precision and generalizability; Identify areas of further research needs.
Speaker(s)
Facilitator
Iris Goetz, MD, MSc
Eli Lilly and Company, United Kingdom
Epidemiologist, Global Health Outcomes
Facilitator
Thomas Rhodes
Merck & Co., Inc., United States
Director, Comparative Outcomes and Evidence