The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
Launch of Mesh: a new online platform co-created by its users and aiming to improve Community Engagement
by The Editorial TeamToday,The Global Health Network launches Mesh: a new online platform co-created by its users and aiming to improve Community Engagement with health in low and middle income countries.
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia
by Henok Negussie, Thomas Addissie, Adamu Addissie, Gail DaveyThis study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.
Good Clinical Practice in Resource-Limited Settings: Translating Theory into Practice
by The Editorial TeamThis guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.
Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon
by Nchangwi S Munung, Godfrey B Tangwa, Chi P Che, Laurent Vidal, Odile Ouwe-Missi-Oukem-BoyerUniversities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.
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 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
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.
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.
Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.