Grant: Operating Grant

Medication use and health care costs increase steadily with the aging of Western societies, and the ever increasing number of drugs available on the market. Overall, new drugs and treatments contribute to the improvement of the population health and increasing life expectancy. However, there are concerns about potential adverse effects of some medications and it is not always clear which of the alternative drugs that are currently used to treat a given disease are the most effective. Thus, evaluation of comparative effectiveness and safety of treatments is a top priority for both the health research and the society at large. Evaluations of the effects of treatments on the health outcomes typically rely on large long-term studies and have to account for differences in both the characteristics of the patients and the dose and duration of treatment. Scientific validity of the results and conclusions of such studies depends critically on the accuracy of statistical methods used to analyze such complex data. The overall objective of our proposal is to develop new statistical methodology for analyzing large studies of comparative effectiveness and safety of medications. The proposed new methods will account for the changes over time in drug use and doses, and for the complexity of biological processes linking medication use and the clinical, socio-economic, behavioral and environmental characteristics of the patients with the clinical outcomes such as mortality, infections or hospitalizations. These new methodological developments will build on our ongoing research on flexible statistical methods for analyzing effects of treatments and risk factors that change over time. Our new methods will help efficient identification of adverse effects and accurate comparison of therapeutic effectiveness of alternative drugs used to treat many diseases. This, in turn, will permit optimizing drug prescribing practice, to minimize the risks and maximize therapeutic benefits.