Pharmacoepidemiological studies are essential in the post-licensing surveillance of vaccines in order to evaluate the potential benefits and risks of vaccines used in common practice. Surveillance is required to detect rare or unanticipated vaccine adverse events and to ensure confidence in vaccination. Epidemiological studies provide data on the long-term protection conferred by vaccination, and the incidence and associated mortality of, and population susceptibility to, diseases preventable by vaccine. These studies also allow verification of the compatibility between strains contained in the vaccine as well as circulating strains.
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Background: Eliminating hepatitis C is hampered by the costs of direct-acting antiviral treatment and the need to treat hard-to-reach populations. Access could be widened by shortening or simplifying treatment, but limited research means it is unclear which approaches could achieve sufficiently high cure rates to be acceptable. We present the statistical aspects of a multi-arm trial designed to test multiple strategies simultaneously and a monitoring mechanism to detect and stop individual randomly assigned groups with unacceptably low cure rates quickly.
View Article and Find Full Text PDFStudy Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350.
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Article Synopsis
- A multi-national observational study was conducted in Germany, Sweden, and the UK to assess the cardiovascular safety of prucalopride, a medication for chronic constipation, by comparing it with polyethylene glycol (PEG).
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