FDA releases finalized Clinical Trial Imaging Endpoint Process Standards
The FDA released a finalized industry guidance April 27 that will help sponsors optimize the quality of imaging data obtained in clinical trials that support approval of drugs and biological products, according to a news release from the U.S. Federal Register.
This release finalizes drafted guidance previously published by the FDA on March 5, 2015.
Additionally, the guidance will address imaging acquisition, display, archiving and interpretation process standards the FDA deems important when imaging is used to assess a trial's primary endpoint.
"The guidance describes the minimum standards a sponsor should use to help ensure that clinical trial imaging data are obtained in a manner that complies with a trial's protocol, maintains imaging data quality and provides a verifiable record of the imaging process," according to the release.
The following are sections in the guidance that outline imaging process topics sponsors should ensure to address:
- Choice of imaging modality.
- The importance of centralized image interpretation for an imaging-based primary endpoint.
- Whether image interpretation should be blinded to clinical data.
- How often image evaluations should be performed.
- How soon after acquisitions should images be interpreted.
- What procedures should be standardized for an imaging-based clinical trial primary endpoint.
- Whether existing imaging process standards are sufficient for the trial's primary endpoint.
- And what should be considered when augmenting existing medical practice imaging standards to create trial-specific standards.
Additional changes made from the 2015 guidance include clarifying the recommended role of a centralized image interpretation process and the quality control process, streamlining the description of the recommended approach to incidental findings and to discordant image interpretations, and highlighting the interrelationship between a clinical protocol and an imaging charter.
A recent graduate from Dominican University (IL) with a bachelor’s in journalism, Melissa joined TriMed’s Chicago team in 2017 covering all aspects of health imaging. She’s a fan of singing and playing guitar, elephants, a good cup of tea, and her golden retriever Cooper.