Articles

FIGO's updated recommendations for misoprostol used alone in gynecology and obstetrics

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. 

Cups or Cash for Girls (CCg) Trial in Western Kenya

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.

Pharmacovigilance in pregnancy

Cochrane Adverse Effects Methods Group Webinar on How to Overcome the Challenge of Reviewing Adverse Effects

The Cochrane Adverse Effects Methods Group presented a webinar on 'How to Overcome the Challenges of Reviewing Adverse Effects'. View an edited version of this webinar or download the slides.

DSMBs and clinical trial safety

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.

Scoping available resources and tools - WWARN survey

Scoping available resources and tools used by investigators to set up and conduct malaria clinical trials in low and middle income countries within malaria endemic settings. Participate in the survey.

My Career in Pharmacovigilance

Health Research Saving Lives - The CHAPAS Trial

This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.

Building Teratovigilance Capacity in Africa

Genome-wide association study of nevirapine hypersensitivity in a sub-Saharan African HIV-infected population

Trying to identify genetic biomarkers of nevirapine hypersensitivity.

My pharmacovigilance PhD journey

Read the story of my pharmacovigilance PhD journey

My journey to a pharmacovigilance PhD

Read the story of my pharmacovigilance PhD journey.

Global Pharmacovigilance User Survey

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

Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool

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.

Drug Safety Glossary

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!  

Cochrane Crowd

Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.

Malaria in Pregnancy Consortium Safety Tools and Resources

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.

Clinical ResearchWorkshop - Malawi

AERSMine - an adverse event data mining tool

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.

PAPER - an assessment of how adverse events from clinical trials are reported in published papers

A recently published paper in PLOS Medicine has investigated how adverse event data from clinical trials are summarised and consequently reported in published papers.