Table 2 Checklist for the design of future studies on molecular markers
Key points | Action | Cornerstones |
|---|---|---|
Treatment | Use standard drug regimen | WHO guidelines |
Patient follow-up | Adapt follow-up to the drug tested | WHO guidelines |
Prevalence of mutations | Do not test SNP close to fixation | < 50% |
Rate of therapeutic failure | Do not test drugs with high failure rate | > 25% |
Level of immunity | Clearly define the target population | < 5 years old/all ages; depending on the transmission level |
Level of transmission | Genotype for multiplicity of infection | MMV-WHO 2007 guidelines |
Level of transmission | Genotype for reinfection/recrudescence | MMV-WHO 2007 guidelines |
Gene polymorphism | Genotype all known alleles of target gene | Provide separate and cumulative analysis for codons tested |
Data report | Link each patient (adequate or failure) with point mutation or wild type | Provide nb. of: Adequate wild-type Adequate mutated Failure wild-type Failure mutated |
Multi-arms study | Do not aggregate data from different areas, drug regimen, and study periods. Do not mix retrospective/prospective studies | Provide complete data and link for each arm of the study |
Quality control | PCR for diagnosis and genotyping | WWARN reference labs |