Medpace and Medidata imaging experts will discuss the role of Quantitative Imaging Biomarkers in clinical trials. The value of quantitative image analysis in early phase drug discovery is apparent in providing surrogate biomarkers for trials across therapeutic areas. Imaging is often part of eligibility assessment for patients as well as an endpoint for making go-no-go decisions about investigational products. Quantitative image analysis is needed to generate imaging biomarkers from patient images acquired at participating sites. Several examples of quantitative imaging biomarkers will be illustrated during the presentations including:
- Oncology Progression Criteria: RECIST and other measures
- Neuroscience trials based on volumetric brain mapping
- Non-Alcoholic Steato-Hepatitis (NASH) therapeutic trials using Proton Density Fat Fraction measured by MRI (MRI-PDFF) mapping of the liver
Each of these indications and imaging biomarkers present unique challenges to clinical trial management and execution. Experts will discuss Medidata and Medpace seamless solution that facilitates image data management and quantitative analysis of patient imaging data for reporting of safety and efficacy endpoints to regulatory authorities.