Monitoring antimalarial safety and tolerability in clinical trials: a case study from Uganda.

ABSTRACT:

Background

New antimalarial regimens, including artemisinin-based combination therapies (ACTs), have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials.

Case description

Between 2002 and 2007, eleven randomized, controlled clinical trials were conduc

SUBMITTER: Staedke SG 

PROVIDER: S-EPMC2464601 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature