title: The perils of PCR: can we accurately 'correct' antimalarial trials?
abstract: During follow-up in antimalarial drug trials, treated subjects can be newly infected. PCR correction is used to distinguish this re-infection from drug failure (recrudescence) and to adjust final drug efficacy estimates. The epidemiological, biological and technical limitations of PCR correction and how this can lead to misclassification in drug trial outcomes are underappreciated. This article considers these limitations and proposes a framework for reporting, interpreting and improving PCR correction of antimalarial trials.
authors.affiliation: Division of Infectious Diseases, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC 27599, USA.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Juliano
authors.forename: Nahla
authors.initials: N
authors.lastname: Gadalla
authors.forename: Colin J
authors.initials: CJ
authors.lastname: Sutherland
authors.forename: Steven R
authors.initials: SR
authors.lastname: Meshnick
mesh_terms: D000962:Antimalarials / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D016133:Polymerase Chain Reaction / Q000379:methods*
chemical_list: D000962:Antimalarials