We would like to invite independent researchers, local health officials and regulators to take part in a study investigating the context of clinical trial research in resource-limited settings.

This study will be based around participatory action research (PAR). By definition, PAR is ideal for our purposes because it directly involves the individuals experiencing a situation in identifying issues and determining solutions.

The reason behind the research
The generation of new knowledge through research and development has been the major factor contributing to improvements in health in the 20th century. The WHO has prioritised research into high burden diseases of developing countries and recognises the importance of generating local, context specific knowledge to increase effectiveness of existing interventions and addressing unmet health problems. There is also increasing appreciation of the value of research conducted in developing countries to contribute to both the national and global evidence base. Non-commercial investigator initiated clinical trials are critically important for establishing the evidence base for health interventions that would otherwise not be commercially viable. They identify vital research areas that are unaddressed by the global community due to insufficient local knowledge and are important for early access to appropriate novel interventions. For these reasons they are a powerful tool for addressing health concerns in developing countries. Many international bodies now advocate for strengthening research capacity in developing countries and supporting locally-led research agendas. However, there is a paucity of knowledge regarding what local research agendas are and what support is required. Furthermore, there is international recognition that trials have become too cumbersome and the regulations and guidelines are often overwhelming and cited as an impediment to research. It is important then to conduct research to pin down exactly where these problems occur, how improvements might be made and also, through participatory research, identify where difficulties are being overcome and subsequently share these examples of successful practice.

Research Aim
Our aim is to characterise the clinical trial research activities of independent investigators in resource-limited settings, to determine what is impeding these activities and to identify examples of successful practice that can be translated to other contexts.
Objective 1: To learn what clinical trial research is being undertaken by independent investigators in resource-limited settings and to understand local research interests.
Objective 2: To understand the processes involved in conducting a clinical trial in resource-limited settings and where investigators have had successes and difficulties.
Objective 3: To understand the health research institutional structure and investigators motivations for doing research in participating research sites.

Target research profile
We would love to hear from independent investigators in resource-limited settings who want to, or have already initiated, designed and led their own clinical trials. We would also like to talk to local regulators and health officials to help determine the wider context of research agendas and their constraints.

The research setting

To narrow down the scope of this research we have had to limit the context that we will be investigating to non-commercial research that is conducted in resource-limited settings with high levels of all cause disease burden. Our guiding parameters for this are Low or Lower Middle income countries (World Bank definition) that fall within the lower 40% of the following indicators: All cause age standardised DALYs per 100,00 (WHO), Research and Development Expenditure (% GDP)(World bank), Scientific and technical journal articles (World Bank) and Researchers in R&D (per million people) (World Bank).

What will be involved and what do I gain from participating?
The ethos of our work at Global Health Trials is that it should be participatory. Research participants will be collaborators in the research, helping to identify key issues and at the same time learning and benefiting from the experience. PAR is cyclical, as we learn from investigators the findings will be shared, thereby improving the situation as research progresses. We will be using social research methods and may ask you to take part in questionnaires, interviews, group discussions and exercises. All contributors will be acknowledged as participatory investigators and findings will be published on the Global Health Trials website in line with the cyclical nature of this methodology. This cycle of feedback will benefit other researchers and allow refinement of ideas and a consensus to develop. This provides opportunities to publicise your research, make global connections and gain recognition for your work. Your level of involvement is entirely up to you, your interest and the time you have available. It can range from:
• Completing questionnaires
• Conference call discussions (with web based exercises)
• In-depth site visits.

Contact information

We would love to learn from your experience as researchers in resource-limited settings and I hope that you will consider taking part in this exciting research.

If you are interested in taking part in this research, or you think you know someone that would be suitable, please contact me through the Global Health Trials networking facility or by email.

Thank you very much.

Sam Franzen

Global Health Clinical Trials
Tel: +441865 857570
Email: sam@globalhealthtrials.org

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