Our clinical research studies, conducted locally and in malaria areas (in South Africa and elsewhere in Africa), aim to contribute to decision-making at a policy level. Our data is for instance, pooled with data from research groups in other areas of the world contributed to the Worldwide Antimalarial Resistance Network (WWARN). This collaboration maps malaria medicine resistance and its drivers globally. As there are countries where resistance has been confirmed to all currently available malaria medicines, there is an urgent need for new treatments. The first clinical step to develop new malaria medicines involves studies in healthy adults, which we conduct with participants identified from our adult volunteer database. This database provides our team with a source population who are contactable and willing to be involved in our Cape Town-based clinical research studies. We also have an interest in finding the optimal way to conduct antimalarial clinical research and may investigate this within our studies. The world-class quality of all our research is driven by our research staff, who coordinate selected resources for The Global Health Network (for trials in South Africa, for research nurses and for pharmacovigilance globally) creating a synergistic relationship to contribute to enhancing clinical research standards in this region. WWARN resources are also shared with Global Health Trials, building capacity within the broader clinical research community and allowing for standardization of international malaria clinical research. The dynamic nature of this model results in a sustainable and optimised collaborating centre.
SEACAT evaluation: Interactions between malaria and HIV drugs in people living with HIV in South Africa, an example of the one of our ACT consortium projects.
It is important to continually question the way clinical research is performed. This ensures that study conduct is appropriate to answer the research question and that data obtained are accurate. For instance, we have investigated how certain clinical trial results (data) are obtained from the information given to us by our study participants. We found that the information reported about their health and use of medicines can be shaped by the way we question them about these things. It may also be affected by the context of the research (e.g. a trial with healthy volunteers in Cape Town compared to a trial with malaria patients in Tanzania). This may impact the way safety and efficacy of the medicines used in research is measured. We are now working with others who conduct similar antimalarial research to harmonise the best questioning methods to obtain these critical data points.
The Worldwide Antimalarial Resistance Network (WWARN) is a multidisciplinary, global network of malaria research experts. WWARN works to provide the information necessary to prevent or slow antimalarial drug resistance, in turn, reducing the number of people falling ill and dying from malaria. WWARN's mission is to provide comprehensive, timely, quality-assured evidence to track the emergence and spread of malaria drug resistance, and improve the efficacy of existing antimalarial medicines and new drugs in development. Some of WWARN's key activities include:
- Providing the malaria community with a reliable and standardised data collection platform to facilitate data sharing, pooled data analyses, and the application of these findings to provide evidence for policy makers and drug developers, to optimise the therapeutic life of existing and new antimalarial drugs;
- Collaborating with laboratories across the world to provide support and advice to improve the analysis of antimalarial drug regimens during clinical trials, and in turn, enhancing overall quality to the research data captured.
The recruitment process for volunteers in clinical research studies is resource intensive. Our experience is that local community understanding of clinical studies, particularly those in healthy volunteers, is limited. We were motivated to develop an adaptive ongoing initiative to recruit and retain individuals for inclusion in future trials. Our community awareness program, includes awareness days offering wellness testing at local malls, targeted job-specific recruitment (accessing populations with flexible enough schedules to take part in these trials) and a community based recruiter. Interested individuals will be pre-screened and those eligible will be invited to attend an information day at the clinical research centre (consisting of a tour of he facility and a debunking of clinical trial jargon). The face-to-face approach is complemented by our website designed specifically to inform prosective volunteers about what participating in a clinical trial entails, including video clips of past participants' commentary. This design enhances community awareness and transparency, while serving as a recruitment aid.
Global Health Trials is a web-based facility developed by a collaboration between many research organisations that work in the field of global health. It is open access and free. The ethos of this initiative is that those working on trials in resource limited settings can access and support each other. Whatever their role and whatever disease they work on. Researchers can then work together to share guidance,tools and resources in order to improve trials and make them easier and more efficient to conduct. This helps to address questions related to disease of poverty. This website also provides guidance material, standard documents and training resources. Global Health Trials' vision aligns with our commitment to equipping our staff to do their job well Our staff lead the local regional faculty of Global Health Trials, and the international Global Research Nurse Network.