Developing Drugs for Optical Imaging

Draft Guidance on Clinical Trials for Optical Imaging Drugs in Surgery

This draft guidance provides recommendations for the design and approval of clinical trials for optical imaging drugs used in surgical procedures. Key considerations include trial design, safety, efficacy endpoints, and statistical analysis.

Key Highlights

• Trial Design and Population
  • Includes intrasubject designs (control for individual variability) and parallel-arm designs (ideal for clinical outcome data).
  • Trial populations must be carefully selected to align with the drug’s intended use.
• Endpoints and Efficacy
  • Primary endpoints should focus on tumor resection or the delineation of vital structures during surgery.
  • Independent raters should assess images with agreed-upon measures to ensure unbiased evaluations.
• Safety Considerations
  • Identifies potential toxicities of optical imaging drugs and emphasizes the need for risk minimization procedures during trials.
• Blinding and Bias Reduction
  • Blinding strategies must be implemented to reduce bias, with prespecified approaches for handling events and missing data.
• Statistical and Sensitivity Analyses
  • Encourages sensitivity analyses to evaluate the robustness of drug effect estimates.
  • Recommends prespecifying strategies for missing data based on event type and context.

Public Comment

Stakeholders are invited to submit comments by 08-Apr-2025, ensuring the final guidance is robust and comprehensive.

This draft guidance is pivotal for advancing the development of optical imaging drugs, ensuring safety, efficacy, and reliability in surgical applications.

Source: https://www.regulations.gov/docket/FDA-2024-D-3780/document

Region: United States of America