Clinical trials for new treatments have certain requirements: a controlled environment, an informed and willing pool of patients or subjects, and the scientific equipment and expertise necessary to closely monitor trial participants. Trial sites must be capable of operating in full compliance with current Good Clinical Practice and Good Laboratory Practice (cGCP/cGLP) — the regulatory standard for clinical research.
Until recently, very few clinical trials to evaluate new TB drugs have been conducted over the past half century. In anticipation of a scale-up of global TB drug clinical development, the TB Alliance launched the first comprehensive assessment of clinical trial sites for their potential use in large-scale TB drug trials to understand the global capabilities to support increasing numbers of TB drug clinical trials. The clinical trials site assessment included more than 90 sites across the globe: in Africa, Asia, Eastern Europe, and North and South America. Potential clinical sites and site laboratories were evaluated for their ability to perform registration-standard Phase II and Phase III TB drug trials. There was a particular emphasis on laboratory capability in handling sputum samples from TB patients, and on a site's ability to conduct cGCP/cGLP-compliant studies.
Results from this study are available to the public. The database not only enables the identification of appropriate sites, but highlights the infrastructure gaps of sites needing improvements.