Introduction: High-quality randomised controlled trials (RCTs) provide the most reliable
evidence on the comparative efficacy of new medicines. However, non-randomised studies …

To complement real‐world evidence (RWE) guidelines, the 2019 Structured Preapproval
and Postapproval Comparative study design framework to generate valid and transparent …

Purpose Real‐world evidence (RWE) includes data from retrospective or prospective
observational studies and observational registries and provides insights beyond those …

In alignment with the International Council of Harmonization's strategic goals, a public-
private consortium has developed a structured template for planning and reporting on the …

Aim Real-life analysis of overall survival (OS) trends among metastatic breast cancer (MBC)
patients may help define medical needs and evaluate the impact of public health …

Real-world data (RWD) and the derivations of these data into real-world evidence (RWE)
are rapidly expanding from informing healthcare decisions at the patient and health system …

Purpose Defining a study population and creating an analytic dataset from longitudinal
healthcare databases involves many decisions. Our objective was to catalogue scientific …

Background Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious
in inducing clinical remission at week 12 (W12) and maintaining clinical remission at W52 in …

Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of
efficacy and safety of medical interventions. More recently, a new paradigm is emerging …

Much has been written about real-world evidence (RWE), a concept that offers an
understanding of the effects of healthcare interventions using routine clinical data. The …