Clinical Trials Imaging Consulting
The need to understand the benefits and pitfalls of using medical imaging as a surrogate endpoint in clinical trials. The operational aspects of Blinded Independent Central Review. The application of Response Criteria used for endpoint determination in oncology and other therapeutic areas.
Medical Imaging Technology
Advances in imaging technology can be used to develop new imaging biomarkers.
Understanding, applying, operationalizing and training on response criteria will have an impact on the outcome.
Monitoring reader performance is essential to validating outcomes.
Medical Imaging Protocols
Rapid advances in imaging technology can result in more complicated imaging protocols. Efficient protocols that drive image quality deliver the best results.
Reading paradigms are therapeutic area and operationally specific.
Site Qualification and Training
Training sites on imaging protocols and proving they can deliver quality images is important.
Reader Qualifications and Training
Readers should be chosen based on their qualifications and experience. Training on the protocol and response criteria is essential.
Due Diligence on Results
Capital placement in the pharmaceutical and biotechnology domain requires independent due diligence of early reported results.
Inter-reader and site versus central review discrepancies exist and cause concern. Understanding and explanation of the differences to regulators is critical.