Home » FDA Issues Final Guidance on Imaging-Based Clinical Trial Endpoints
FDA Issues Final Guidance on Imaging-Based Clinical Trial Endpoints
Drugs Regulatory Affairs
Sponsors conducting clinical trials using imaging-based primary endpoints should consider the choice of modality — such as echocardiography or single-photon emission computed tomography — as well as centralized image interpretation and how often image evaluations should be performed, according to final guidance from the FDA.
The agency also recommends trial-specific procedures for imaging that extend beyond the imaging performed as part of standard medical care.
Sponsors should consider logistical issues when considering imaging modalities for a phase 3 trial. “Imaging modality upgrades and malfunctions are sometimes unpredictable,” the guidance states.