Do you conduct clinical trials on anti-malarial treatment? We want your input!

28 November 2011

When evaluating the safety of antimalarial drugs, the results of individual clinical trials/studies, syntheses of trial/study reports, and analyses of pooled individual participant harms data are all influenced by the methods used to collect such data. However, there is no consensus regarding the detail of how clinical research participants should be questioned about their health and treatments, or how staff should assess and/or record the data reported.   

ACT Project 16 has provided some novel empirical evidence of the impact of subjectivity on medical history, adverse event and concomitant medication malaria clinical trial participant reports, influenced to some extent by the mode of elicitation (i.e. question type) and trial context. Developing optimal tools with which to detect and record participant-reported safety data in various malaria clinical research contexts requires consideration of these and other relevant issues. Following the example of those in other therapeutic areas working towards harmonised methods for detecting and recording participant-reported harms data, we are planning to survey which methods are used by malaria clinical researchers. Thereafter, we will facilitate a dialogue between those who interested in working towards consensus about the appropriate design of relevant and feasible methods. We consider this would enhance the field of malaria clinical research and contribute to the safer use of antimalarials in key target populations.   

If you are interested in hearing more about this project please contact Liz Allen at Elizabeth.allen@uct.ac.za.  Click on the link to view her slides from the MRC Clinical Trial Methodology Conference which took place in Bristol, UK in October 2011.  You can also read this projects Phase 1 results as published in the Trials Journal