DSMBs and clinical trial safety
by Global PharmacovigilanceThe 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.
GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic
by John Whitehead, Peter HorbyThis paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. This article was first published in PLOS.
Malaria in Pregnancy Consortium Safety Tools and Resources
by Global PharmacovigilanceResearch 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.
The European Mobile Laboratory, EMLab, was the first EBOV diagnostics unit deployed to the outbreak epicentre by WHO in March 2014.
Trial design for evaluating novel treatments during an outbreak of an infectious disease
by John Whitehead, Piero Olliaro, Trudie Lang , Peter HorbyThis article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. The paper was published in Clinical Trials.
Research Nurse Jerome Ackeneck discusses what's involved in his role on a Cameroonian HIV Study
Are you a research scientist working in Global Health? Or an institution looking for partners to run a clinical trial? Site Finder is for you.
In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.
Professor Bongani M Mayosi from the Department of Medicine, Groote Schuur Hospital & University of Cape Town describes the transofmation of the science cohort in South Africa.
In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.
ISARIC-WHO Clinical Characterisation Protocol for Severe Emerging Infection (Master)
by ISARIC Coordinating CentreThe ISARIC-WHO Clinical Characterisation Protocol for Severe Emerging Infection, with supporting documents. Under WHO ERB review.
The basic requirements for new sites wanting to take part in clinical research - What sites need to know!
by Caroline SibekoClinical Research Laboratories for Trials in Global Health in Central Africa
by ALI Innocent, akindeh, Prof Wilfred F. MbachamThe authors present the story of building a succesful research laboratory in Cameroon, including how they managed building up the infrastructure, equipment maintenance, staff training.