S2 E6 – #RealTalk on Clinical Trial Design and Execution

Naim Alkhouri and Dr. Rashmee Patil of the South Texas Research Institute join the Surfers to discuss practical challenges and issues in conducting on-time, on-target NASH clinical trials

The January 29 FDA webcast on NASH Drug Development suggested the need for larger, longer clinical trials with more patients in the overall dataset. This week, Stephen Harrison, Naim Alkhouri and Rashmee Patil of the South Texas Research Institute (each of whom manages hepatology clinical trial sites) discuss how to make trials run better and more smoothly. The trick is be realistic about what is feasible and not to let “right” become the enemy of “good.” The three researchers discuss specific protocol criteria that hamper success and share illustrative stories from their past. If you design clinical trials, need the results of trials to move your project or product forward, or assess trials for investment purposes, this episode will give you a clearer sense of when and how it makes sense to be more flexible in your design criteria and expectations. At the end, Louise and Roger each commented on how much they had learned.