From Tabletop to Trial: Enabling Embedded Pragmatic Trials and Selective Safety Data Collection

About this session

Pragmatic trials have arguably been characterized more by promise than actual progress. New developments are poised to help shift the balance. The use of pragmatic elements in clinical trials—including broad eligibility criteria, use of electronic health records and patient-reported outcomes—has been a popular topic of conversation, but also a source of great hesitation. While these options create new opportunities for regulatory decision-making, they also present challenges around sponsor oversight and selective safety data reporting.To address these challenges, TransCelerate, in collaboration with FDA’s CDER Center for Clinical Trial Innovation, conducted tabletop exercises to test trial designs under real-world conditions. This session will share key insights and approaches to support more effective design and execution of pragmatic trials. This session will also touch on a new TransCelerate effort to shed light on the use of pragmatic designs to improve safety data collection in connection with ICH E19.

Speaker

• ZJ

  Zhanna Jumadilova

  Biopharmaceutical Physician Executive, Pragmatic Clinical Trials, R&D · Pfizer Inc.

  Speaker