Findings from an assessment of global clinical trial sites and mycobacteriology labs for their capacity to conduct registration-standard TB drug trials performed by the TB Alliance were published in the November 2009 issue of the International Journal of Tuberculosis and Lung Disease. Of the clinical trial sites surveyed, only 50% were judged to be capable of being ready to conduct registration-standard TB drug trials in less than six months, while an additional 32.1% could were estimated to need 6–12 months to meet such criteria. The remaining sites would need more a year’s worth of preparation.
The survey collected data from 84 clinical trial sites and 72 associated mycobacteriology laboratories in 39 countries throughout the world, including 15 of the 22 WHO-designated TB high-burden countries. The study indicated that developing adequate capacity to fully evaluate the potential new TB drugs currently in the global portfolio will require significant capacity-building efforts.
Mycobacteriology laboratories, as a group, were less prepared than clinical trial sites; less than 30% were deemed capable of being readied within six months. Nearly one in three laboratories assessed was determined to require more than a year of preparation before meeting the standards required for conducting registration-grade investigations.
Considering a clinical site and the associated mycobacteriology lab as a unit, slightly over 60% of the trial sites have the potential to be ready within a year.
As part of the assessment process, trials sites were rated for their capability to conduct trials compliant with Good Clinical Practice and Good Laboratory Practice standards With the assistance of clinical research organizations and internationally recognized mycobacteriology experts, the ratings were determined by considering the experience and number of staff at each site, the number of patients the site was capable of supporting, the adequacy of the surrounding patient population to reach enrolment goals of TB trials, and the presence and suitability of standard operating procedures and processes.
The findings of the study are available in a single database, which contains comprehensive site assessment data and supporting documents for individual sites. The TB Alliance has made this database available to the public for the benefit of the entire TB drug development community.
This past decade has seen a resurgence of TB R&D, and therefore high-quality sites and laboratories with the capacity to conduct large-scale trials will be in increased demand as the first and subsequent waves of new TB drugs progress along the development process. In addition, there will be increased demand for sites as more new treatments for drug-resistant TB move toward clinical testing. The TB Alliance and Tibotec’s joint development program of TMC207 calls for parallel development of the compound for both drug-sensitive and drug-resistant disease. Popularization of this model would lead to an even greater need for a broader network of clinical trial sites. Most individual sites would only be able to conduct one Phase II or Phase III trial at a time.
Working to develop adequate, global clinical trial capacity is an extremely important endeavor, and one that the TB Alliance is helping to accomplish both through its site assessment study as well as through its Phase III REMoxTB study, which is helping to catalyze the actors and systems necessary for healthy and efficient processes to test and register new TB treatments. But, the larger task of developing a robust, global network of sites capable of supporting the growing global pipeline will not be achieved without concerted and appropriately resourced efforts from stakeholders throughout the world. Estimates indicate that the cost of establishing necessary resources and infrastructure are approximately $1–2 million per site per year. This work must be undertaken, otherwise the world faces the threat of critical work to develop vital, novel TB regimens being impeded and delayed by lack of adequate infrastructure to complete the research.