regulatoryinnovation
Description

A number of companies have been presenting results on how RWD could in the future substitute control arms in clinical trials. The basis of these presentations were comparisons of control arms from clinical trials with the "synthetic" control arms derived from RWD, and the comparisons of hazard rations derived from the completed clinical trials and hazard ratios derived by analyzing the experimental arm and the "synthetic" control arm.
The goal of the proposed session is to initiate conversations of how to use the above research and start establishing best practices for designing clinical trials with "synthetic" arms derived from RWD. The topics for the panel discussion would include: what are the proper outcomes and data sources, what is the process for selecting patients and building the control arm, pre-planning of required sample size and collection of safety data.

Ability Level: Intermediate

Session ID: 503204

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