Clinical drug efficacy is a key parameter used by health policy makers to formulate malaria treatment guidelines. The Clinical Module aims to enhance the amount of clinical data available, increase the scientific capacity in endemic countries and provide evidence to policy makers on resistance or susceptibility to various antimalarials.

The Clinical Module is working towards these goals by:

• Facilitating the inclusion in the WWARN Data Repository of results from clinical drug efficacy studies carried out by research groups, National Malaria Control Programmes, and surveillance networks. This will include up-to-date data on the emergence of resistance by location.
• Creating a standardised process to facilitate the collection of diverse datasets from studies taking place around the world.
• Optimizing analytical tools to accommodate this diversity and increase comparability of results between heterogeneous studies.
• Developing standardised methods and support systems to assure a high quality of source data.

What we do

The Clinical Module is gathering diverse datasets examining clinical drug efficacy in the standardised WWARN Data Repository. In particular, we manage data about the clinical response of patients with malaria who are treated with specific antimalarials.

Community malaria survey, Kyela District, TanzaniaThe Clinical Module has been heavily involved in the development of a suite of tools that transform contributed data in any format into cross-comparable standard formats and a set of derived variables that are displayed in WWARN Explorer, a web-based visualisation tool. These data applications are designed to help record, clean, curate and analyse data, using a transparent methodology according to WHO guidelines for the assessment and monitoring of antimalarial drug efficacy. View clinical data in the WWARN Explorer preview.

Six core variables are derived from submitted data to allow for the generation of standardized efficacy estimates by survival analysis. Key subgroup analyses (e.g. selection by age group or parasitaemic threshold) are also available.

Study reports, which are attached below, contain a summary of the data curation process along with in depth analysis of treatment efficacy in a format that can be used for personal reports and/or publications. In addition, the Clinical Module will also undertake and present regular reviews of geospatial and temporal trends in drug efficacy across the malaria endemic regions.

Procedures, clinical trial guidelines and essential documents for conducting clinical trials are being developed by the Clinical Module. These study design documents will facilitate the conduct of clinical drug efficacy studies for researchers with varying needs and technical capabilities. A data entry template is also being produced, and will eventually be accompanied by online curation tools and syntax files helping users to perform offline curation and data analysis.

The Clinical Module will be involved in the cross-module analysis to correlate molecular markers and in vitro and pharmacological results with in vivo efficacy outcomes.

For more information, contact clinical@wwarn.org.

Study Reports: