Methods and techniques for clinical trials on antimalarial drug efficacy: Genotyping to identify parasite populations
The use of polymerase chain reaction (PCR)-corrected cure rates has become accepted as end-points in regulatory clinical trials and for monitoring antimalarial drugs as it improves overall comparability. In order to achieve harmonization and to overcome the considerable variation in sampling procedures, genotyping techniques and interpretation of data, the Medicines for Malaria Venture convened a meeting, cosponsored by WHO, of experts in the ﬁeld of Plasmodium genotyping to achieve consensus on standard operating procedures that would be applied in all specialist malaria genotyping laboratories.
This publication provides an overview of the discussions during an Informal consultation organized by the Medicines for Malaria Venture and cosponsored by WHO on 29-31 May 2007, and of the agreed recommendations, structured around six topics: (i) sampling scheme, (ii) methods of blood sampling and sample storage, (iii) genotyping strategy, (iv) analyses and outcome classification, (v) quality control and (vi) genotyping of P. vivax.
Recommended genotyping procedures
These recommended genotyping procedures (RGPs) were introduced following the 2007 informal consultation on Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations, during which experts requested the formulation of standard genotyping procedures. They are a compilation of protocols from several laboratories (Muséum national d’Histoire naturelle, Paris, France; Swiss Tropical Institute, Basel, Switzerland; Karolinska Institute, Stockholm, Sweden; Ifakara Research Institute, Ifakara, Tanzania).
These RGPs do not include the names of suppliers, product brand names because suppliers and products differ by countries, as do PCR conditions between laboratories. However, these forms can be easily transformed into standard operating procedures by filling in the laboratory specific supplier's names.