Clinical Pharmacology Quality Assurance Program for Global HIV and Co‐Infection Drug Development

When the acquired immunodeficiency syndrome emerged in the 1980s, the United States National Institutes of Health established research networks to conduct clinical trials with the pharmaceutical industry to identify effective antiretroviral therapeutics. The clinical trials networks included laboratory centers with academic pharmacology laboratories measuring drug concentrations to allow for the estimation of pharmacokinetic parameters and correlation with pharmacodynamic outcomes. Adoption of comprehensive quality assurance initiatives was key to ensuring the integrity of pharmacology sampling and laboratory data provided by clinical sites and laboratories. Subsequently, this infrastructure facilitated rapid responses to co-infection pathogens such as hepatitis C virus, Mycobacterium tuberculosis, and severe acute respiratory syndrome coronavirus 2. In 2008, the Center for Integrated Global Biomedical Sciences at the University at Buffalo was awarded the initial National Institute of Allergy and Infectious Diseases contract for the Clinical Pharmacology Quality Assurance Program. Since 2015, over 4,500 tutorial certificates for research staff and laboratories have been awarded on topics including the conduct of clinical pharmacology research protocols and bioanalytical method validation for antiretroviral assays. A bioanalytical peer review program for ensuring the quality of the assay methods has approved over 350 assays for > 100 analytes in 21 human biological matrices. An ISO-17043 accredited external proficiency testing program has completed 35 rounds for 15 analytes. Also, a laboratory assessment program was established that utilizes international laboratory and regulatory standards, and multiple mechanisms for training, assistance and guidance to participants. This report summarizes the development of the CPQA program over the last decade.