Invitation to join collaborative Study Groups

7 October 2011

There are many outstanding, critical questions around malaria drug resistance.  Where are the hot spots of resistance?  Has artemisinin resistance spread from Western Cambodia?  Can we predict how far and how fast resistance may spread? How do the dosing strategies and pharmacokinetics of particular drugs affect the clinical outcomes?

A single, routine antimalarial drug efficacy study rarely has the statistical power to answer these kinds of questions - a full analysis requires integration of data from many regions and time periods.

Earlier this year, WWARN facilitated the formation of the first Study Group, to undertake the largest pooled analysis of pharmacokinetic (PK) and pharmacodynamic (PD) antimalarial data in the world.  Data from a total of 7529 lumefantrine samples have been contributed from 19 individual studies and this pooled data set is now being analysed to better understand the relationship between drug levels and clinical parameters.  Building on this successful initiative, WWARN is now inviting participants for four new Study Groups to investigate further aspects of antimalarial resistance:

ACT Africa Baseline Study Group: a pooled analysis of baseline information on parasitological response to artemisinin combination therapy in Africa

AS-AQ Dose Impact Study Group: assessing the effect of mg/kg dosing strategies on the risk of treatment failure in patients treated with currently recommended ACTs

Amodiaquine PK/PD Study Group: a pooled individual patient PK/PD data analysis to provide the necessary evidence to inform recommendations on dosage and use in key target populations.

ASAQ/AL Molecular Marker Study Group: investigating the role of candidate molecular markers of lumefantrine and amodiaquine resistance in clinical outcomes of ACT

WWARN Scientific Director Carol Sibley said: “WWARN is ideally placed to act as a forum for collaboration, by bringing researchers together to address these pressing issues. Those who take part can benefit from increased visibility for their work, even if unpublished. By working together we have the potential to maximise the value of data being collected from different regions and deepen our knowledge of antimalarial resistance.”

Data from individual studies will be transformed to a common format to provide the Study Group with a much larger sample size to help uncover subtle trends or sub-population effects.  Each Study Group will be able to plan, analyse and publish the results of pooled analysis, ensuring that everyone involved benefits from results gained from larger sample sizes and information with a longer time frame and from a wider geographic area. Read a more detailed description of the aims, outcomes and entry requirements of each study.