In analytical observational studies, researchers try to establish an association between
exposure (s) and outcome (s). Depending on the direction of enquiry, these studies can be …

The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have
recently become widely used in the field of post-licensure vaccine safety monitoring to detect …

Interventional researchers face many design challenges when assessing intervention
implementation in real-world settings. Intervention implementation requires holding fast on …

Objectives: The goal of comparative effectiveness analysis is to examine the relationship
between two variables, treatment, or exposure and effectiveness or outcome. Unlike data …

Background: Although randomized controlled trials are often a gold standard for determining
intervention effects, in the area of practice-based research (PBR), there are many situations …

Purpose Ideally, the objectives of a pharmacoepidemiologic comparative effectiveness or
safety study should dictate its design and data analysis. This paper discusses how defining …

The tree-based scan statistic is a statistical data mining tool that has been used for signal
detection with a self-controlled design in vaccine safety studies. This disproportionality …

Background There is limited research on healthy volunteers' perceptions of the risks of
Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns …

Recent clinical trials demonstrating that hormone replacement therapy (HRT) does not
prevent coronary heart disease in women have again raised doubts concerning …

Background Considerable attention now focuses on the use of large-scale observational
healthcare data for understanding drug safety. In this context, analysts utilize a variety of …