Drug safety Archives

Conundrum in pharmacoepidemiology: Contextualising biases in case-crossover studies

Written by

Dr Kiyoshi Kubota has pioneered innovative methods for analysing data with biases inherent to case-crossover studies.

Dr Kiyoshi Kubota, physician and pharmacoepidemiologist based at the NPO Drug Safety Research Unit Japan, has pioneered innovative methods for analysing data in case-crossover studies. By tackling biases inherent to case-crossover studies, including within-subject exposure dependency and lack of pair-wise exchangeability, his methodologies offer a clearer lens for evaluating medication safety and effectiveness. The contributions of Kubota and his collaborator, […]

A matter of choice: Free to choose medicine in the 21st century

Written by

Bartley J Madden’s work on a structural improvement to the US FDA’s drug approval process has spanned 20 years.

The US Food and Drug Administration’s system for medicine approval is lengthy and expensive, and only 1 in 12 drugs in human clinical trials obtain approval. Bartley J Madden of the Madden Center for Value Creation at Florida Atlantic University proposes an alternative free to choose medicine (FTCM) pathway. He suggests that with the advice of their doctors, patients should […]

How treatment epidemiology can shape future healthcare research

Written by

Dr Aisling Caffrey is an Associate Professor of Health Outcomes at the College of Pharmacy, University of Rhode Island. For over a decade, Dr Caffrey has been studying the treatment of diseases in real-world clinical practice, an area Dr Caffrey has termed ‘treatment epidemiology’. Dr Caffrey’s expertise is in comparative effectiveness and safety research, where she studies the benefits and harms of healthcare interventions, […]