Pediatric Cancer Dataset Gaps, FDA ‘High Bar’ Make Use Of External Control Arms Difficult
Executive Summary
European data privacy regulations could further complicate efforts to build external control arms using real-world data that are housed outside the US, experts said at advisory committee meeting on use of real-world evidence in pediatric cancer drug development.
You may also be interested in...
External Controls: FDA Guidance Provides Clarity But Does Little To Remove Hurdles
Agency discourages use of externally controlled trials in all but a very limited number of situations truly ripe for such an approach; new draft guidance discusses at length the various confounding factors that can introduce bias into a comparison between an investigational treatment and an external control using either real-world data or data from another clinical trial.
US FDA Raises Problems With EU Data Protection Reg, But Are They Among Those Misunderstanding It?
An FDA blog post says some inspections have been hindered and application assessments soon could be delayed by the EU General Data Protection Regulation (GDPR), but experts argue the law includes directions to allow data sharing and remain compliant.
US FDA Crowdsourcing Pediatric Regulatory Science Research Ideas
With more than 1,600 pediatric and related clinical trials in house, the agency wants ideas for how they can be analyzed to advance pediatric drug development.