Laboratory Challenges Conducting International Clinical Research in Resource-Limited Settings

Abstract:There are many challenges to performing clinical research in resource-limited settings. Here, we discuss several of the most common laboratory issues that must be addressed. These include issues relating to organization and personnel, laboratory facilities and equipment, standard operating procedures, external quality assurance, shipping, laboratory capacity, and data management. Although much progress has been made, innovative ways of addressing some of these issues are still very much needed.

[1]  Jeffrey Wasserman,et al.  Strengthening laboratory systems in resource-limited settings. , 2010, American journal of clinical pathology.

[2]  J. Darden,et al.  Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. , 2008, Journal of pharmaceutical and biomedical analysis.

[3]  A. Abimiku Building laboratory infrastructure to support scale-up of HIV/AIDS treatment, care, and prevention: in-country experience. , 2009, American journal of clinical pathology.

[4]  O. Doumbo,et al.  Promoting good clinical laboratory practices and laboratory accreditation to support clinical trials in sub-Saharan Africa. , 2012, The American journal of tropical medicine and hygiene.

[5]  D. Birx,et al.  Laboratory challenges in the scaling up of HIV, TB, and malaria programs: The interaction of health and laboratory systems, clinical research, and service delivery. , 2009, American journal of clinical pathology.

[6]  S. Owusu-Agyei,et al.  Good Clinical Laboratory Practices Improved Proficiency Testing Performance at Clinical Trials Centers in Ghana and Burkina Faso , 2012, PloS one.

[7]  Timothy Amukele,et al.  The Good, the Bad, and the Unknown: Quality of Clinical Laboratories in Kampala, Uganda , 2013, PloS one.

[8]  Cathy A Petti,et al.  Laboratory medicine in Africa: a barrier to effective health care. , 2006, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[9]  R. Redfield,et al.  Role of secondary level laboratories in strengthening quality at primary level health facilities' laboratories: an innovative approach to ensure accurate HIV, tuberculosis, and malaria test results in resource-limited settings. , 2013, Diagnostic microbiology and infectious disease.

[10]  L. van Damme,et al.  Obtaining Valid Laboratory Data in Clinical Trials Conducted in Resource Diverse Settings: Lessons Learned from a Microbicide Phase III Clinical Trial , 2010, PloS one.

[11]  Timothy Amukele,et al.  External quality assurance performance of clinical research laboratories in sub-saharan Africa. , 2012, American journal of clinical pathology.