Efficacy Standards For 55 Diseases In 5 Years: FDA, Critical Path And CDISC’s Ambitious Plan
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.
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Validation rules for standardized clinical trial data terminology could allow sponsors to check their data in the same way FDA does.
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.
Overwhelming number of stakeholders urge FDA to choose the Clinical Data Interchange Standards Consortium’s Operational Data Model instead of the competing Health Level 7 standard for clinical data submissions.