Please note that this seminar is cancelled.
We will review fundamentals of clinical trials and their role in improving health, the criticisms and challenges surrounding their present place in biomedical research, and new developments in clinical trials methods and a possible future. First principles of clinical trials (e.g., randomization and blinding to control for known and unknown biases, careful selection of patient criteria and endpoint to improve precision) will be covered. The growing costs and continued failures of clinical development pipelines, as well as new attention on rigor and reproducibility, will be introduced. Discussion of new approaches in clinical trials methodology (e.g., adaptive designs, platform trials, precision medicine, randomized registry trials) to address evolving needs of patients, practitioners and health care systems will serve to stimulate thinking about the continued role of clinical trials.