Imaging as a Biomarker: Standards
for Change Measurements in Therapy
14-15 September 2006, NIST, Gaithersburg, Maryland
Imaging as a biomarker
of drug response is becoming an increasingly important field of research.
The Food and Drug Administration (FDA), the National Cancer Institute (NCI),
and the Centers for Medicare and Medicaid Services (CMS) have agreed to
collaborate on improving the development of cancer therapies and outcomes
for cancer patients through biomarker development and evaluation <http://www.fda.gov/oc/mous/domestic/FDA-NCI-CMS.html>.
A similar effort across the National Institutes of Health's (NIH's) Institutes
and Centers (ICs) is being planned. Biomarkers are biological indicators
of disease or therapeutic effects that can be measured by in vivo biomedical
imaging and molecular imaging in particular, as well as other in vitro or
laboratory methods. Recent work has shown that biomedical imaging can provide
an early indication of drug response by use of X-ray, CT or PET-CT.
Many sources of uncertainty
exist in imaging as a biomarker. Biological variability, for example,
is a factor both drug- and patient-dependent and thus difficult to characterize
or model. However, other uncertainties are associated with the image data
collection platform and the robustness of software tools required for
reliable, quantitative measurement of change over time, such as tumor
volume, radioactive tracer activity, or contrast agent dynamics. All these
sources of uncertainty significantly affect the statistical power of clinical
drug or therapy trials.
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 of clinical trials for drug
response. The costs of a drug submission to the FDA by the pharmaceutical
industry may soon exceed $1 billion. The use of standardized imaging methods
may reduce these trial costs.
The scope of this
workshop is focused on the need to standardize imaging methods for data
collection and data analysis in the context of drug or radiation therapy
trials. Suggested topics for discussion are:
- Instrument quality
control over the time sequence of a trial
- Harmonization
of data collection across different commercial imaging platforms
- Creation of standardized,
objective performance metrics for image-analysis software using reference
image databases or test beds
- Standardized statistical
methods for change measurement
- Archival and access
methods for image storage, related meta-data, and clinical outcome data
- Innovative methodologies
for the integration of image and other data for clinical decision making
Workshop participants
should address the following questions with respect to the above topics:
- What technological
innovations are at stake?
- What is the economic
significance of the innovations?
- What technical
barriers to the innovations impede progress to the marketplace?
- At what stages
of innovation (R&D, Production, Marketplace, End Use) do the technical
barriers appear?
- What parts of
the technical barriers are measurement science or standards development?
- What are the
potential solutions to the measurement and standards development problems?
- Who are potential
providers of solutions?
- Are there critical
roles for agencies of the federal government?
If you would like
to participate as a sponsor or session leader at the workshop, please
contact:
Linda Beth Schilling (linda.schilling@nist.gov,
301-975-2887), Ram Sriram (ram.sriram@nist.gov,
301-975-3507) or Laurence Clarke (lclarke@mail.nih.gov,
301-435-9190)
Online registration
is available at: https://rproxy.nist.gov/CRS/conf_ext.cfm?conf_id=1674
For more information,
also visit: http://www.nist.gov/public_affairs/confpage/060914.htm
Updated workshop
information and registration links are available on the NIST U.S. Measurement
System website <http://usms.nist.gov>.
Printable version
of this information is available in PDF format.
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