title: Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries.
abstract: There has been a significant increase in the number of clinical drug trials (particularly phase III) being conducted in developing countries for infectious diseases such as HIV, malaria, and tuberculosis. Laboratory results provided by medical testing laboratories in the region are critical to ensuring the safety of patients and the generation of good quality data. A number of well accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines govern the conduct of clinical trials internationally. Good Clinical Practice guidelines remain too vague with respect to sample analysis to ensure practical implementation in these laboratories. In their strictest sense, Good Laboratory Practice guidelines refer to the analysis of samples from non-clinical studies. A specific set of minimum standards or requirements for practical implementation of clinical trial requirements in medical testing laboratories in the developing world is urgently required.
authors.affiliation: Department of Molecular Medicine and Hematology, University of Witwatersrand and National Health Laboratory Service, Saxonwold, South Africa. wendy.stevens@nhls.ac.za
authors.forename: W
authors.initials: W
authors.lastname: Stevens
mesh_terms: D019985:Benchmarking; D002986:Clinical Trials as Topic / Q000592:standards*; D003906:Developing Countries; D003955:Diagnostic Tests, Routine / Q000592:standards*; D015507:Drugs, Investigational; D017408:Guidelines as Topic; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008288:Malaria / Q000175:diagnosis / Q000188:drug therapy; D014376:Tuberculosis / Q000175:diagnosis / Q000188:drug therapy; D006113:United Kingdom
chemical_list: D015507:Drugs, Investigational