This article is part of the network’s archive of useful research information. This article is closed to new comments due to inactivity. We welcome new content which can be done by submitting an article for review or take part in discussions in an open topic or submit a blog post to take your discussions online.
The goal of Tropical Medicine Clinical Trials Research Programme is to promote and make easier the conduct of non-commercial clinical research across all diseases in resource-poor settings.
Clinical trials establish the evidence base for prevention and treatment of disease and are critically important in tropical medicine. This importance is threefold: there is the greatest potential for improving health in numerical terms, there is enormous potential gain from relatively simple interventions, and these areas have been under represented in clinical trials to date.
Clinical trials in tropical medicine typically have endpoints that are severe disease outcomes or mortality. They more often involve children and are sponsored by not-for-profit organisations. There are also specific situations that merit more and better clinical trials to inform policy such as disease outbreaks, including those with pandemic potential, in displaced populations, refugee camps and natural disasters. These very specialist situations and environments need a research focus in order to identify highly practical and appropriate interpretation of guidelines and regulations to enable rapid and flexible trial implementation whilst maintaining the same degree of attention to ethical standards and to quality of processes and data as any international trial.
There is a high level of activity with externally sponsored product development trials. However disease management trials are equally important and product development trials alone do not leave sites with the ability to run their own broad programmes. To encourage more locally led trials we need to support researchers and provide skills and guidance in setting questions and operating protocols.
We aim to establish a dedicated, collaborative, non-disease-specific web forum to help tropical medicine researchers with clinical trial operations, design, methods and interpretation of regulations. This tool will offer guidance whilst also identifying problems and potential solutions and encouraging the sharing of best practices. Using a participatory mixed methods action research approach we will conduct a situational analysis to identify the real barriers and issues. The data gathered will be used to continuously update the web forum and to develop resources and guidance to enable the conduct of clinical trials to be both appealing and straightforward.
The main objective of this research is to identify where the interpretation of GCP and other regulatory requirements is problematic in resource poor settings and quantify the impact these issues are having. The identification of the problems will lead to studies that will generate new tools that will be made available on the web forum. This will be a continuous iterative process so continuing the theme of participatory action research, with the web forum providing the open-access, open source and fully collaborative vehicle.
There is a need for well trained and qualified clinical trialists to lead and design their own trial programmes in developing countries in order to catch up with the career structures in the west. Therefore another aim of this collaboration is to develop training courses and resources to meet specific gaps. At present there are diplomas and MSc clinical trial courses that are taught and available through distance learning. Whilst these are good, they are focussed on industry and US/European regulatory needs. Our research will also help to guide the design and content of courses specifically focussed on developing country clinical trials based on what we have shown to work locally in vulnerable populations. Our findings will also enable funders interested in capacity building to direct their resources appropriately and product developers to select trial sites. Although we are focusing our research on tropical medicine we expect some of our findings to be generally applicable to anyone engaged in non-commercial trials.