Table 1.

Considerations for initiating malaria diagnostics for clinical trials

Basic clinical trial considerations

What clinical and research question(s) are being asked?

What is the size and scope of the trial? Phase I, II, or III?

What are the diagnostic purposes of the assay?

Is qualitative or quantitative detection required (i.e., positive/negative vs. enumeration of parasites)?

Is there a need to detect and quantify any parasite infection, whether subclinical or not? Is there a need to identify the species? Or is there only a need to diagnose and document clinical episodes?

Is the assay used for clinical diagnosis (targeted vs. screening), to measure response to treatment, or for another experimental question, or epidemiologic endpoint (e.g., surveillance)?

Which parasite stages are of interest?

Is the sample collected in a resource-limited or resource-rich setting?

Is the laboratory testing performed on-site or in a core laboratory in the same country or overseas?

Basic epidemiologic considerations

Region of high, low or epidemic transmission intensity? Travelers' malaria?

What is the human population being studied? What is known about host variability (genetics, cultural practices, exposures, epidemiology, age, rates of co-infection, reproductive status/parity)?

What is the diversity of local/endemic Plasmodium populations? (intra- and inter-species variability, drug resistance)?