BIOMARKER VALIDATION

Comprehensive research and analysis to establish the validity of specific biomarkers is conducted through exhaustive review of the medical literature, and consultation with investigators at the Massachusetts General Hospital and beyond. Technology assessment and cost-effectiveness analysis is also provided as part of the validation process.

Effective use of biomarkers in imaging demands that a biomarker be completely validated for its contemplated role in a pre-clinical or clinical trial. Failure to establish this suitability risks the very integrity of the trial at issue.

The MGH Center for Biomarkers in Imaging, built on the proven imaging expertise of the Massachusetts General Hospital Department of Radiology has a large number of qualified radiologists and other researchers available to validate an imaging biomarker for a given pre-clinical or clinical application.

Depending on the biomarker at issue, validation may involve a comprehensive review of the peer-reviewed literature, suggestions for further validation research, or the actual conduct of validation research. Beyond examining suitably to assess safety and effectiveness, the Center also integrates the considerable resources of the Massachusetts General Hospital Institute for Technology Assessment, one of the country’s leading technology assessment groups. Using cutting-edge modeling techniques, the Institute is able to provide a sponsor timely technology assessment and cost-effectiveness analysis, supplying data invaluable to fully assessing the potential of any new therapy.

All biomarker validation services provide the requesting party with a detailed report outlining the strengths and weaknesses of a given biomarker, together with an objective, scholarly opinion as to its suitability for a given trial.

More information on Biomarker Validation may be obtained by contacting the Center, info@biomarkers.org