Structural Nested Models To Assess The Safety And Effectiveness Of Generic Drugs

• PI:                        Ravi Varadhan, PhD, co-investigator Jodi Segal, MD, MPH
• Funding:             The U.S. Food and Drug Administration 
• Status:                 Ongoing

Generic drugs are cheaper than brand-name drugs. However, there is general reluctance among patients to take generics because of the perception that they may not be as safe and effective as brand-name drugs. This project will develop tools for statistical analysis which can help determine, in a reliable manner, whether the generic version of drugs are as safe and effective as the brand-name drugs.

The project's first aim is to develop a rigorous, state-of-art, causal inference approach for comparing the toxicity and efficacy of generics and branded therapeutics that will be applicable to claims databases. The second aim is to leverage the EMR data linked to claims, to enhance the methods developed in Aim 1. In the third aim, the research team proposes to train the FDA scientists in implementing these methods.

Links:

Read more about the project here.