Introduction to the Application

In recent oncology trials,
surrogate endpoints represented by progression-free survival and objective response rate
have primary roles. These endpoints are imaging-based outcomes assessed
through RECIST (Response Evaluation Criteria In Solid Tumors) response categorization
according to the percent change of the tumor burden before and after treatment.

However, radiologic measurements of baseline and post-treatment tumor burden may be inconsistent between readings. This application estimates how the objective response rate would vary due to the measurement variability when the same or another radiologist re-assesses the tumor response.