This was the course project for Introduction to RCT course(spring 2019). It was an individual assignment requiring each student to identify a promising clinical intervention and draft a proposal for a hypothetical NIH Phase III, two-parallel-group randomized clinical trial to evaluate its efficacy. For my proposal, I selected a promising experimental drug, LY3298176, which was being developed for the treatment of type 2 diabetes. At the time, LY3298176 had just completed Phase II trials, showing encouraging results. In the proposal, I addressed key issues related to randomized clinical trials: safety, outcome variables, hypothesis formulation, power, stopping rules, etc. The proposal is linked down below.
Excitingly, LY3298176 is now widely recognized as the phenomenal drug tirzepatide! It has been approved by the FDA for the treatment of type 2 diabetes and for weight management. Witnessing its transformation—from an experimental drug known to a small group of scientists to a globally celebrated medicine that improves the quality of life for people worldwide—has been truly inspiring. This journey has deepened my passion for drug development, and I look forward to contributing meaningfully to this field in the future.