Combining Information from Clinical Trials and Observational Studies to Evaluate Safety

Christiansen C. Combining Information from Clinical Trials and Observational Studies to Evaluate Safety. Paper presented at: American Statistical Association Joint Statistical Annual Meeting; 2002 Aug 12; New York, NY.

Randomized Controlled Trials (RCTs) for drug efficacy and safety often exclude or under-represent potentially vulnerable patient populations, such as the elderly and those with comorbid conditions. After drug approval and marketing, identification of safety concerns in vulnerable populations emerges slowly because of difficulties making causal inference with observational or administrative data. In this talk, we describe methodology and applications for combining different types of research data to evaluate safety of drugs. Combining information to study health care safety of non-drug therapies where RCTs are uncommon also is discussed.