The evolving threat of antimicrobial resistance- Options for Action
by World Health OrganizationThis article explains the process of data management operations within clinical trials from start to finish.
Ethical issues in human genomics research in developing countries
by Jantina de Vries, Susan J Bull, Ogobara Doumbo, Muntaser Ibrahim, Odile Mercereau-Puijalon, Dominic Kwiatkowski, Michael ParkerGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS are taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.
We present this clinical trial as a gold standard example. This study addressed a key question in the management of severely ill children. It was conducted to a very high standard across 3 African countries. This article links to a short film that explains how this trial can be an example to all researchers in resource-limited settings and shows that research can and should be done.
Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)
by Lawrence MbuagbawDuring the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.
Regional faculties provide opportunity for increased professional networking and clinical trial skill sharing at a local level. The Global Health Regional Faculties are being set up to facilitate activities that will increase and support clinical research in specific regions this is achieved by sharing skills, knowledge and experience between disease areas, job roles and research sites. Examples are opening up spaces on training courses or for meetings, supporting exchange or observational site visits. This article explains how interested groups could set up a faculty in their region
Health research: the challenges related to ethical review and informed consent in developing countries
by Raffaella RavinettoAn article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.
An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish
The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH
What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.
Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.
Considerations for pharmacovigilance and safety reporting.
Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.
What is the definition of a clinical trial? Is there an international consensus? Read on to find out.