Industry, FDA seek standards for medical imaging in clinical trials

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The Drug Information Association (DIA), in collaboration with FDA and the Medical Imaging Contrast Agent Association (MICAA), will host a workshop from Oct. 2-3 in Bethesda, Md., that will focus on standardizing the use of medical imaging in clinical trials.

The workshop, Medical Imaging Continuum: Path Forward for Advancing the Uses of Medical Imaging in the Development of New Biopharmaceutical Products, will provide updates on the harmonization and standardization of the key elements required to meet the FDA review process and Proposed Draft Regulatory Guidance of 2011.

Attendees will discuss "Metrics for Quantifying the Quality of Imaging Enterprises in Clinical Trials" and "How to Standardize Image Acquisition, Transfer and Analysis." Potential outcomes will include:

  • Endorsement of a rigorously defined metrics that quantify the quality of imaging enterprises in biopharmaceutical development;
  • An explanation of the issues surrounding the quantification of adjudication rates across therapeutic areas and imaging technologies;
  • Harmonization of imaging as a quantitative measure of drug-induced changes in multi-center clinical trials; and
  • The adoption of a standard, open-source, internet-based application for transferring data from sites of acquisition to central repositories.

It is cosponsored as well by the Council on Radionuclides and Radiopharmaceuticals (CORAR), PhRMA and the American Medical Informatics Association (AMIA).