Assessment of global capacity to conduct tuberculosis drug development trials: do we have what it takes?
OBJECTIVE: To assess clinical trial sites and associated mycobacteriology laboratories for their capacity to conduct registration-standard tuberculosis (TB) drug trials and develop a database of assessed sites and laboratories.
SETTING: Assessments of clinical trial sites and associated mycobacteriology laboratories were conducted in 39 countries from 2006 to 2008.
DESIGN: Sites were interviewed using a set of questionnaires to assess the clinical site, pharmacy, data management, regulatory, ethics and importation requirements and mycobacteriology laboratory. Each site and laboratory was rated as able to conduct TB drug registration trials within 0-6 months, >6-12 months, >1-2 years and >2 years.
RESULTS: Eighty-four clinical trial sites and associated mycobacteriology laboratories in 39 countries were assessed. Of the clinical trial sites, 50% were judged capable of being ready within 6 months, 32.1% in 6-12 months and 14.3% in 1-2 years. Three sites would be ready in more than 2 years. Of the 72 mycobacteriology laboratories, 27.8% could be made ready within 6 months, 37.5% within 6-12 months and 27.8% within 1-2 years.
CONCLUSION: This survey indicates that developing adequate capacity to fully evaluate the compounds now in the clinical phases of development will require significant capacity-building efforts.
International Journal of Tuberculosis and Lung Disease (2009) 13(11) 1367-1372