Grant: New Investigator Salary Award - PA: Drug Safety and Effectiveness

This proposal outlines my ambitions for the next 5 years of my research career as part of my application for a New Investigator award in the priority area of drug safety. My planned primary focus is in expanding the application of network meta-analysis to include observational data along with data from randomized trials in analyses for safety. A variety of limitations related to assessing safety from RCTs are known to exist and observational studies may offer a solution to some of these challenges. At the same time, it will be important to assess potential bias within observational studies and account for them quantitatively in analyses. In the research proposal three objectives are proposed: the first objective of this program will be to develop a framework which will incorporate adjustments for these perceived biases at the individual study level (year 1). As a second objective, I will demonstrate use of this framework while answering a series of drug safety questions outlined below (years 1-3). As a third objective, we plan to report empirical findings related to how the addition of observational data impacted the extent of available evidence for meta-analysis, summary estimates, clinical conclusions, and how bias adjustments impacted results (years 3-4). I believe the proposed work is well suited to the priority topic of the study of drug safety and is well aligned with the objectives of the Drug Safety and Effectiveness Network.