Tuesday, September 12, 2017 3:15:41 PM
Excerpts from speech:
Quote:
We’re also advancing the use of ‘Master Protocols’ to enable more coordinated ways to use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient.
This approach is particularly relevant when it comes to targeted drugs. These are drugs that may intervene on markers that are relevant across many different disease subtypes. We may, for example, want to evaluate these different targets simultaneously, as part of one large study. This could give us a better way to understand the comparative benefits of a drug across different settings. To enable these master protocols, it’s often important to do molecular patient screening. This can lead to the development of a diagnostic that can also be used to guide patient care.
Quote:
Our goal is to see how we can accelerate methods that improve our ability to use advanced tools to meet FDA’s gold standard for regulation.
These methods are being applied to both common and rare diseases. FDA is also collaborating with scientists to use similar computational tools to develop natural history models, based on placebo arms in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, and muscular dystrophy. If we’re able to make better use of rigorous, reliable natural history models, especially for rare diseases, it can help make clinical trial recruitment more efficie.
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