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Pharmaceuticals / Trial Design / Regulatory Affairs / Clinical Trials

FDA Releases First Proposed Development Tool for Bronchitis Drugs

Jan. 15, 2014

An FDA effort to facilitate the creation of  drug development tools (DDT) that can be used by multiple drugmakers already appears to be bearing fruit, as one such tool for chronic bronchitis is already being considered by the agency.

The FDA’s draft clinical outcome assessment (COA), designed to measure symptoms of acute bacterial exacerbation of chronic bronchitis in patients with chronic obstructive pulmonary disease, is to be used in Phase II studies.

Once finalized by the FDA, drugmakers developing applicable products can use the electronic tool to measure the symptoms of acute bacterial exacerbation of chronic bronchitis. It is currently qualified as an endpoint in Phase II superiority studies.

Ultimately, it is intended to be used “as a primary or secondary endpoint in confirmatory clinical trials,” the FDA said. “Additional development work is needed to further assess measurement properties over the course of an exacerbation, including ability to detect meaningful change in response to an acute intervention.”

The FDA recently published draft guidance laying out a blueprint for qualifying DDTs such as biomarkers, COAs and animal models within a specific context of use in drug development. The goal is to make qualified DDTs that can aid in the development and review of multiple companies’ drugs.

Comments on the draft COA, docket no. FDA-2013-D-1630, are due by April 8.

To read the attachment, visit www.fdanews.com/ext/resources/files/01/01-13-14-DDTText.pdf. — Robert King

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