Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a Microbicide Phase III Clinical Trial Institute of Tropical Medicine
BACKGROUND: Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical ...