Recent work has shown that biomedical imaging can provide an early indication of drug response, but there are many sources of uncertainty that limit the quantitative use of imaging as a biomarker. These include variables in the image data collection platform, and the robustness of software tools required for reliable, quantitative measurement of subtle changes such as tumor volume, radioactive tracer activity or contrast agent dynamics. The development of standards for image quality control, image data collection and benchmarking of change analysis software tools, as well as image-specific statistical methods, could significantly reduce the size and cost of clinical trials for drug response.

The National Institute of Standards and Technology (NIST) will host a two-day workshop, Sept. 14-15, 2006, in Gaithersburg, Md., to assess the need for standardizing imaging methods for data collection and data analysis in drug or radiation therapy trials. The workshop, "Imaging as a Biomarker: Standards for Change Measurements in Therapy," is co-sponsored by the National Institutes of Health, the Food and Drug Administration, the Pharmaceutical Research and Manufacturers of America, and the Radiological Society of North America, and several industry and technical associations. The cost to attend is $75. Additional details, including an agenda and complete list of sponsors, are available at http://usms.nist.gov/workshops/bioimaging.htm.

The workshop is one of a series on the U.S. Measurement System (USMS) convened by NIST to assess and document the nation's priority measurement and measurement-related standards needs for technological innovation, U.S. industrial competitiveness, safety and security, and quality of life.