FDA Publish Guidance on Clinical Trial Imaging Endpoints

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The purpose of this guidance is to assist sponsors in the use of endpoints that depend on the results of imaging tests in clinical trials of therapeutic drugs and biological products. This guidance focuses on the imaging standards that we regard as important when imaging is used to assess a primary endpoint, or an endpoint component, in a clinical trial intended to confirm a drug’s efficacy. These standards can be used by sponsors to ensure that the imaging data are obtained in a manner that complies with a trial’s protocol, that the quality of imaging data is maintained within and among clinical sites, and that there is a verifiable record of the imaging process. By considering the topics highlighted within this guidance, sponsors can obtain clinical trial imaging data in a manner that minimizes variability and enhances data quality and the ability to detect drug treatment effects.

This guidance describes the procedures recommended for collecting and interpreting medical images in efficacy trials. The guidance does not address whether or not specific measurements are clinically meaningful and are acceptable for drug approval. Even though many of the concepts within this guidance also can be applied to clinical trials of 35 diagnostic products and devices, those clinical trials often involve more technical considerations. We encourage sponsors to consult guidances directed toward those types of products. For considerations involving development of imaging drugs, see the guidance for industry Developing Medical Imaging Drug and Biological Products (Parts 1, 2, and 3).

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA 4), we committed to certain performance goals (see letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record). This draft guidance addresses one of these goals with the creation of a guidance document that addresses the “imaging standards for use as an endpoint in clinical trials.” Although this guidance addresses imaging standards, it does not address the use of any specific imaging endpoints nor does it address a process of qualification of imaging biomarkers for use in clinical drug development. For issues that may be relevant to such a process, see the draft guidance for industry Qualification Process for Drug Development Tools.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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