FDA Therapeutic Area Standards Would Have To Clear Industry Testing
This article was originally published in The Pink Sheet Daily
Validation rules for standardized clinical trial data terminology could allow sponsors to check their data in the same way FDA does.
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Repeated trial failures in this rare disease space have given birth to new alliances – one backed by Critical Path and the other by the CureDuchenne advocacy group – that aim to model disease progression much more accurately through data sharing and rigorous analysis.
Agency’s goal of setting standards for clinical data in 57 therapeutic areas in five years looks unlikely to be met, according to the timelines given by members of the Coalition For Accelerating Standards and Therapies.
Building on the Alzheimer’s disease Therapeutic Area Standard, the groups hope to create measurement standards for clinical trials in a variety of therapeutic areas, but funding remains an acute challenge. In order to succeed, each project needs to be faster and cheaper than the Alzheimer’s effort.