In the wake of the 21st Century Cures Act, FDA has shown increased amenability to use of real-world data sources to identify patients for synthetic control arms in single-arm clinical trials.
TORONTO, Ontario (PRWEB) August 27, 2020
In a live session taking place on Thursday, September 3, 2020 at 10am EDT (4pm BST/UK) the featured speakers will frame the issues and articulate the common approaches to synthetic control arms in a manner that balances strategic aspects of research design with methodologic rigor on operationalizing the approach.
Single-arm clinical trials—in which all enrolled patients receive active treatment and no one receives placebo control—have long been acceptable to regulatory authorities in those instances in which inclusion of a control arm is either infeasible or unethical. These situations arise particularly in rare diseases and oncology. In the wake of the 21st Century Cures Act, FDA has shown increased amenability to use of real-world data sources to identify patients for synthetic control arms in single-arm clinical trials.
The presentation will benefit professionals working with real-world data in clinical development, oncology and rare diseases, as well as those involved in medical affairs for clinical trials.
Join industry experts David Thompson, PhD, Senior Vice President, Real World Research, Syneos Health ® and Craig White, PhD, Senior Vice President and General Manager, Outcomes Science, ConcertAI for an informative session that includes
open question and answer discussion with the audience.
For more information or to register for this event, visit Using Real-World Data in Single-Arm Clinical Trials: When It’s Done, Why It’s Done, How It’s Done.
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