To overcome differences in study design, data must be contributed to the WWARN Data Repository on individual patients. For more information, see our Malaria Journal paper. High security measures ensure that individual data files will be accessible only to the original contributor, unless the contributor chooses to share their data with others through our secure system. For more information on the treatment of contributed data, see Contributing Data.
Variables required for each submission include the following:
- Patient identifier (anonymised)
- Treatment received, including route of administration, dose and date & time of each dose
- Date & time of each PK sample collected
- Drug/metabolite assayed
- Drug/metabolite concentration at each time point
- Basic information on study site, study design and assay method
These variables will be used to derive variables that indicate antimalarial drug exposure. In this way, all studies presented on the WWARN Explorer visualisation tool will have had outcomes derived using the same statistical method, increasing comparability across studies.
The value of the above pharmacokinetic data is greatly enhanced if it is linked to clinical efficacy data (see variables required) to help us better understand the effect of drug exposure on treatment response. If available, these data will be stratified based on molecular and in vitro data from the same patients. View the Pharmacology Data Management and Statistical Analysis Plan (DMSAP) for a clear and transparent description of the methodology by which WWARN handles and analyses Pharmacology data.
To enhance our understanding of the patient factors that have substantial effects on antimalarial efficacy, we would value inclusion of as much data as possible on the study baseline characteristics of each study patient, such as age, gender, pregnancy status, co-morbidity, concomitant administration of fat/medication, malaria status (e.g. species, disease severity, IPT, healthy volunteer).
