CLINICAL TRIAL DESIGN

Using the proven resources of the Massachusetts General Hospital and the MGH Department of Radiology, clinical trials using validated biomarkers in imaging are custom-designed for specific medical therapies.

One of the most promising aspects of imaging biomarkers is their potential to provide more accurate clinical data in a shorter timeframe and at less cost than traditional trials. Imaging biomarkers also allow for the assessment of parameters that are difficult or impossible to assess with clinical endpoints.

While promising, the use of imaging biomarkers in clinical trials is not a straightforward process, demanding a thorough knowledge of the biomarker at issue, including its strengths and limitations. Failure to incorporate this knowledge into any clinical trial involving an imaging biomarker risks compromising the fidelity of the data generated, as well as the outcome of the trial itself.

The MGH Center for Biomarkers in Imaging, built on the extensive clinical trial experience of MGH Radiology, has the skills and resources necessary to effectively and appropriately apply imaging biomarkers to virtually any clinical trial. To date, the radiologists, researchers, and technologists at MGH Radiology have worked with over 35 companies and better than 30 discrete biomarkers, providing clinical trial experience over a wide range of diseases.

In addition to this industrial experience, the Center also boasts research experience with literally hundreds of imaging biomarkers (Biomarkers Catalog), and a clinical practice that performs over 550,000 examinations and procedure a year.

The MGH Center for Biomarkers in Imaging specializes in working to link trial sponsors in industry, academia and government with the appropriate MGH radiologist, researcher, or technologist with the experience, interest and skills necessary to design clinical trials using appropriate, validated biomarkers in imaging. Radiologists, researchers and technologists are available in a large number of programs covering all organ systems and modalities.

For additional information or initial inquiries regarding Clinical Trial Design, please contact the Center, info@biomarkers.org