Webinar: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, 5 March 2019by The Editorial Team
Sharing expertise and collating information to increase understanding of poor quality medicines globallyby GPV Coordinator
Responding to the growing mandate for researchers to share their clinical data, WWARN is joining with partners to host a 3-day workshop in January sponsored by the British Council’s Newton Researcher Links Programme in order to develop the skills and network needed to produce high quality data capable of maximising the impact of initial findings.
In 2012, the International Federation of Obstetrics and Gynecology (FIGO) produced a chart detailing recommended dosages of misoprostol when used alone, for a variety of obstetric and gynecologic indications. In light of new evidence and through expert deliberation, this chart has now been revised and expanded. The present commentary explain the changes and the decisions made.
The Cups or Cash for Girls (CCg) Trial is currently being conducted in Western Kenya. This trial is investigating whether giving school girls a menstrual cup, cash transfer, or both, has an impact on various deleterious outcomes. This trial offers a unique perspective on safety monitoring and this article discusses why safety monitoring is important in such a trial and how it is being tackled.
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.
This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.
Genome-wide association study of nevirapine hypersensitivity in a sub-Saharan African HIV-infected populationby Global Pharmacovigilance
Trying to identify genetic biomarkers of nevirapine hypersensitivity.
Read the story of my pharmacovigilance PhD journey
Read the story of my pharmacovigilance PhD journey.
Initial content for www.globalpharmacovigilance.org was based on the website coordinators’ own ideas, and has been focused on:
- Consolidating pharmacovigilance (PV)-related content already on the wider Global Health Network (www.tghn.org)
- Linking to external training resources, societies, other special interest groups, and events
- Developing original articles on pertinent topics
- Providing a fora for members to debate the successes and challenges in assessing harm in a variety of contexts
- Developing a growing bank of in-house free e-Learning courses
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!
Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.
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.
A recently published paper in PLOS Medicine has investigated how adverse event data from clinical trials are summarised and consequently reported in published papers.
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.
If you take two different medications for two different reasons, here's a sobering thought: your doctor may not fully understand what happens when they're combined, because drug interactions are incredibly hard to study. In this fascinating and accessible talk, Russ Altman shows how doctors are studying unexpected drug interactions using a surprising resource: search engine queries.