Professor and Chair of Pharmaceutical Outcomes and Policy
College of Pharmacy
Almut Winterstein’s pharmaceutical research centers on the evaluation of drugs in real-world populations for the purposes of improving patient safety.
“Population-based observational studies of drug effects have a critical place in science if evidence from randomized clinical trials is not available,” Winterstein said.
Examples of these evaluations are generally assessments regarding rare safety issues that require large sample size, or of drug effects in special populations, such as children or patients with concurrent chronic diseases or conditions who are rarely included in trials.
Consequently, Winterstein’s research on drug safety and effectiveness has demonstrated a strong focus on pediatrics, psychiatry and infectious diseases. Through analysis of real-world data of millions of patients, Winterstein has been able to address a variety of drug safety concerns, including potential associations between sudden cardiac death or suicide, or the development of hearing loss or permanent ear drum perforations in connection with antibiotic ear drops.
Winterstein has also conducted a variety of studies designed to help tailor and optimize treatment approaches. A significant portion of her work has informed current treatment guidelines, such as her studies on the prophylaxis of certain respiratory infections in infants, which have shaped the American Academy of Pediatrics Red Book Vaccination recommendations.
She has maintained an extramurally funded research program on the effects of drug use among large populations, patient safety and quality. As the PI or Co-PI Winterstein has directed more than $10 million in research support. She has published close to 300 manuscripts and conference abstracts. Winterstein’s team is recognized as a valuable resource with indispensible expertise and an advanced research infrastructure that allows state-of-the-art access to integrated personal health information of over 160 million persons.