Articles - Clinical trials

The patient's ‘voice’ in pharmacovigilance

Pharmacovigilance in pregnancy

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.

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.

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.

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.

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.

ACT Consortium – Pharmacovigilance activities and outputs

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.