CONFIRMATION OF PHENOTYPE IN CLINICAL TRIALS

Appropriate patient selection for clinical trials is accomplished using validated biomarkers in imaging.

Key to successful clinical trials, whether or not they explicitly incorporate biomarkers in imaging is confident identification of trial subjects. The inclusion of subjects who do not actually suffer from the disease or condition under evaluation inevitably impact trial results.

A wide range of imaging modalities and techniques are available to confirm the presence of a specific disease or condition in a potential trial participant (Biomarkers Catalog) allowing confident patient inclusion in a study. For example, bone mineral density measurement, in conjunction with plain radiographs to demonstrate the presence of fractures, can identify those with the decreased bone mineral density and strength diagnostic of osteoporosis. Similarly, MRI can be used to demonstrate the cerebral white matter lesions consistent with multiple sclerosis. Plain radiographs have been used successfully for years to confirm the presence of inflammatory arthritis, such as rheumatoid arthritis.

Using the extensive imaging expertise of the Massachusetts General Hospital Department of Radiology, CBI staff will work with a trial sponsor to identify an imaging biomarker that can confidently and reliably assess for a given phenotype. Special attention is paid to employing imaging modalities that are widely available and easily utilized, ensuring that the identified biomarker may be practically applied to the clinical trial.

To learn more about Imaging Biomarkers and Confirmation of Phenotype in Clinical Trials, please contact the Center, info@biomarkers.org