**This session is part of the Skills Course Package add-on**

Pragmatic randomized clinical trials (pRCTs) are trials conducted in a routine clinical practice setting with minimal disruption to clinical health care (other than randomization) to assess effectiveness and safety of interventions. They require the expertise of pharmacoepidemiologists who understand considerations and methodologic challenges that arise with generating and analyzing real world data compared with traditional “explanatory” RCTs.

This year, the course will focus on emerging methods as the need for rapid, rigorous, and generalizable evidence increases and technologies have improved for clinical data collection. The course will cover high level designs, including the typical attributes of pragmatic trials and then cover the methods for ensuring the generation of robust real world evidence and for leveraging electronic health records and other sources of RWD to improve efficiency of pRCTs and support embedding of pRCTs in health care delivery settings. Operational challenges and lessons learned from conducting pRCTs will be shared along with case examples from PCORI and other invited speakers.

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Jennifer Christian, FISPE

IQVIA

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ICPE 2021 Sessions

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