Projecting Outcomes and Combining Phases in an Oncology Biologics Program

For an oncology biologic program, we worked with the client to combine PoC and dosing studies into a single study based on ability to continuously track outcomes. One of the other key features was continuously projecting where the study would end up, based on data to date. The design provided for stopping the study when an adequate signal was defined. This contrasts with the rigid fixed-sample traditional approach that may leave the sponsor with too much or too little data. Less than halfway through the planned timelines, the predictive probability of success exceeded 94% with reasonably tight credible intervals. View the blog post, “What Presidential Elections Can Teach Pharma.”