Ever wondered how cancer drugs are developed and what role clinical trials play in this process? Prepare to unravel the complexities of this process with our guest, Brooks Ensign. Bringing decades of experience from the pharmaceutical industry and insight from teaching biostatistics, Brooks opens up about the emerging approach of decentralized or hybrid clinical trials, which are transforming patient-centricity, enrollment, retention, and preserving quality of life.

Our conversation takes you through the labyrinth of designing medical studies, where ethics and statistics collide. We uncover the unique aspects of cancer trials compared to other clinical trials, and Brooks' expertise shines as he explains the intricacies of selecting the right study population. We leave no stone unturned as we dig into the different phases of clinical trials, with a spotlight on the revered phase three trial – the gold standard for FDA approval. We unveil the veil off the critical aspects of study design, from the subtle art of randomization and blinding processes to the science of determining the sample size.

We venture into the fascinating world of the regulatory aspects of cancer clinical trials, discussing the importance of baseline assessments and the recruitment process. Brooks shares compelling insights from his encounter with the FDA's Project Optimus initiative, along with the challenges he's surmounted in the realm of clinical trials. So gear up for a riveting episode that promises a deep dive into the processes and intricacies of cancer drug development and clinical trials. Tune in now, and let's explore this complex field together.