Asst Prof Lu Mao receives 3-year NIH award to develop new statistical methods for use in clinical trials

Congratulations to Assistant Professor Lu Mao on the award of a $1.1M 3-year National Heart, Lung, and Blood Institute (NHLBI) award titled “Novel Statistical Methods for Complex Time-to-Event Data in Cardiovascular Clinical Trials.

In clinical trials in chronic diseases including cardiovascular disease, the primary efficacy endpoint is often complex composite endpoints, and even randomized controlled trials can result in non-random cohorts as in the INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED) trial ( NCT02787044).  The application proposes to develop 1) new approaches to the analysis of non-random cohorts arising from the INVESTED trial and 2) an extended framework for the win-loss approach as an alternative to the standard methods which ignore the relative clinical relevance of the component endpoint events.  The statistical methodology to be developed in this project will not only benefit the INVESTED trial but can also be utilized by other randomized controlled trials in chronic diseases including cardiovascular disease that share similar features such as non-randomized cohorts and complex composite endpoints.