Firstly, I would like to quickly introduce myself. I have recently started working for the Global Health Clinical Trials Programme and I will be mainly involved in the research side of the programme’s activities.
While it is commonly acknowledged that clinical trials are becoming increasingly difficult to conduct, there has been little evidence-based research aimed at identifying the barriers to conducting clinical trials, and even less investment within the context of research in developing countries.
Our aim at the Global Health Clinical Trials Programme is to establish a body of evidence-based research that successfully highlights the issues with conducting clinical trials in developing countries and provides an effective framework of resources, tools and advice to overcome these barriers. GlobalHealthTrials.org will be an integral part of this research and will act as a platform to share ideas, get a consensus on the current situations, collaborate with research sites, collect data and disseminate findings.
Our initial goal is to build a picture of the type of work that is being carried out in developing countries and the range of organisations and institutions that conduct this research. Then, most importantly, we need to identify the problems and issues that you as researchers are experiencing. Through this early stage information gathering we will refine our research questions and focus on teasing out the contributing factors and finding solutions to the most pertinent issues - for this to work we really need your help.
We would love to hear about all the key players and stakeholders (staff, participants, regulatory boards, funders, monitoring committees, community members etc.) within your clinical trials and learn about the positive and negative experiences each individual has at every stage of this “organisation”. Through taking a more holistic approach to capacity building and problem resolution we hope to discover more about what makes a successful trial and what can be done to improve every individual’s experience of the trial. More importantly we hope to develop methods to allow a trial organisation to identify its own ways of improving the trial quality and experience.
Please send us any suggestions and ideas for areas to investigate, methods of investigation and insights into any problems you may have experienced or overcome and solutions that you have found. By getting the whole research community to participate in our research we can make sure that our work is pragmatic, inclusive and really gets to the key issues.
Thank you very much and we look forward to hearing your input. I will be regularly updating this blog as our research progresses to talk about our experiences, ideas and findings.
next week at ASTMH we will be presenting a poster, on behalf of the 4-ABC study groups, to present and discuss the methodological and resources-related difficulties faced by non-commercial, externally funded research groups. Best wishes,
it is nice to hear from you Sam. I work on a clinical trial called CHAPAS-3. My country of work is Uganda.we are waiting for approval my the local bodies in Uganda. I will keep in touch.
That is nice to hear Sam. Just looking forward to hearing from you. Will keep you updated.
Global Health Trials has recently set up its Globally Applicable Trial Initiation Participatory Process Map. This map is designed as a guidance tool to help researchers navigate the processes of setting up a clinical trial in any setting. It's a participatory project and we really need your input, so please check it out. The map is attached to an article in the guidance and resources section.
We hope you find it useful.
I am not an investigator, but Ican share some insights on conducting clinical research in resource limited settings.I have been involved as Study Coordinator for operational research and clinical trials in Kenya, in addition, I been a Monitor for several clinical trials and epidemiological studies for HIV and TB vaccines conducted in Kenya, Uganda, South Africa,India, Cambodia and Tanzania. Let me know how I can help in your study
It would be great to hear about your experiences. I have started a Clinical Trial Methodology Research discussion group, perhaps you could share some insights on that page? It would be particularly interesting to learn how clinical trial conduct varied by location and with different groups.