The Data Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC – these are synonymous terms) is a group of individuals put together by the sponsor or CRO (if contracted out) with relevant expertise to carry out the important role of monitoring the safety of a clinical trial study.
Whilst there is much focus on detecting and monitoring safety in both research and clinical practice, there is far less information on the issue of avoiding them. As such, a new adverse drug reaction avoidability assessment tool was developed and tested by the researchers of this paper. Developed in a paediatric research setting, it is hoped that its use could be extended to a variety of settings.
A Drug Safety Glossary has been developed to help overcome some of the difficulties in understanding and using the various terms and phrases used in pharmacovigilance. Many of the terms can vary in how they are interpreted and used - this guide largely draws from relevant ICH (www.ich.org) and/or European regulatory agency definitions. Take a look and let us know if you have any other suggestions!
Research in pregnant and breastfeeding women is a complex area, with both the wellbeing of the mother and child paramount. Careful monitoring of any intervention to treat, or prevent, illness is required to ensure the benefits outweigh any harms. Read this article to find out more and download some of the safety tools developed by experts from the Malaria in Pregnancy Consortium.
A novel application utilising data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has been developed by a Biomedical Informatics team at the Cincinnati Children’s Hospital Medical Center.
Although there is now a good research pipeline of antimalarial drugs in response to the rapid spread of drug resistant malaria, there is very little evidence on how these drugs should best be deployed. The ACT Consortium is a global research partnership of a number of eminent public health and academic institutions in Africa, Asia, Europe and the United States where our projects' Principal Investigators are based. Research focuses around four major themes relating to artemisinin-based combination therapies (ACTs), the first-line treatment recommended by the World Health Organisation for malaria - in Africa and Asia: targeting, access, quality and safety. Including safety as a theme was important as, despite the wide scale use of ACTs, little is known about their long-term effects and their use in vulnerable populations, such as those co-infected with HIV. Moreover, it is clear that there is a need to work towards the pooling of safety data from multiple studies to understand uncommon adverse drug reactions that may not be detected by individual studies.