Introduction An R&D collaboration between the European AIDS Treatment Group, European Liver Patients Association, Treatment Action Group, and Janssen R&D. Description of the case Patients were involved as follows:...
Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess...
Vaccines are biological preparations developed from modified versions of the micro-organisms that cause a disease. Vaccines improve or convey immunity to particular diseases, usually in an effort to prevent...
Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and...
Statistics play an important role in clinical trials in preventing errors, biases, and false inferrences. This article covers some key statistical concepts, such as hypothesis testing, type 1 and...
Introduction Development of a cure/treatment for Duchenne, by the Duchenne Parent Project in collaboration with Leiden University and Prosensa (Biotech partner) – GSK. Description of the case Development of...
The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising...
‘Within-trial decisions’ are decisions made once a clinical trial has already begun, for instance if an unexpected problem comes to light. This article looks at two specific kinds of...
A very important result from the EUPATI project was the development, broad consultation and final release of guidances on the best approach to interaction of patients with pharmaceutical industry-led...
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