The US Food and Drug Administration (FDA) set forth new policies on Thursday for standardization of imaging data collected and managed as part of clinical trials in support of premarket submissions for drugs and biologics.
“Considerable standardization already exists in clinical imaging,” FDA said. But the finalized 31-page guidance provides recommendations for additional standards “that are more specific to clinical trials.”
The guidance is intended to aid sponsors in ensuring imaging data quality and maintaining a record of imaging procedures by minimizing variability. “Minimization of imaging process variability may importantly enhance a clinical trial’s ability to detect drug treatment effects,” FDA added.
Several changes were made to the draft version, issued in March 2015 to revise guidance from August 2011, though this background information is not included in the more succinct finalized version.
According to the draft guidance, describing risk to study subjects in clinical protocols and consent documents, rather than imaging charters, and identifying the use of investigational imaging equipment were among the clarifications needed for standard policy refinement. This information was replaced with several new examples of trial-specific standardization in the final guidance, such as routine bone X-rays—which are “relatively standardized,” according to FDA.
Logistical and technical considerations are covered in a Q&A format for the most part. One of the changes made involves the first subsection—which is no longer presented in the form of a question as it was in the draft guidance—with the last paragraph being the only one that remained unchanged.
A total of 11 factors to consider when determining the appropriate extent of standardization for a Phase 3 clinical trial with an imaging-based primary endpoint are outlined in the guidance. These include: qualifications of imaging technologists, as well as procedures for imaging display and interpretation.
The following section also poses two questions on the extent of imaging process standards in Phase 3 clinical trials that, according to FDA, sponsors should consider “at a minimum.”
For example, on what to consider when improving existing process standards to create ones that are trial-specific, FDA recommends developing an imaging charter to “standardize an array of imaging procedures among the clinical sites, such as the timing of imaging during the trial, details of contrast injection, subject sedation and positioning, image display and interpretation, and image archiving.”
Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry