Beyond randomised controlled trials: using prescription claims data to investigate ‘real-world’ safety of newly marketed medicines

Evidence regarding the efficacy and safety of medicines is mainly derived from randomised controlled trials (RCTs). However, in real life medicines are often prescribed to patients who would have been excluded from participating in RCTs due to factors such as age, multimorbidity, or concomitant medicine treatment. This project will investigate the ‘real world’ use and safety of newly marketed medicines. Data will be sourced from national and international prescription claims databases. This will include data from the Australian Pharmaceutical Benefits Scheme (PBS). This project will apply novel pharmacoepidemiological research methods.

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