Earlier this year, TREAT TB launched a webinar series to strengthen capacity to conduct high-quality clinical trials for multidrug-resistant tuberculosis (MDR-TB). The first webinar brought together eight experts to discuss the challenges faced when implementing MDR-TB clinical trials. The presentations provided an overview of ongoing and future trials and covered various aspects of MDR-TB clinical trial implementation, such as patient recruitment, enrolment and retention, challenges encountered by sponsors and regulatory requirements such as import and export permits.
Over 65 participants from around the world joined the discussion, including clinicians, donors, researchers, representatives from the pharmaceutical industry, and advocates. Following the presentations, speakers and participants addressed common challenges in the implementation of MDR-TB clinical trials and agreed that collaboration with key stakeholders and efficient project management were key components to ensuring the success of a trial.
Common challenges in implementing an MDR-TB clinical trial
MDR-TB trials are challenging for many reasons including methodological limitations that lead to lengthy trials, a lack of consensus on terminology and endpoints for use in trials, and limited coordination between researchers.
Furthermore, for a clinical trial to be successfully implemented, chosen sites require established infrastructure such as laboratory capacity, areas to provide patient care which allow for infection control practices, sufficient drug storage, properly trained staff and principal investigators. Identifying sites with the required facilities can be difficult, as the burden of MDR-TB is often felt in areas where resources are limited. Once suitable sites are identified, the lengthy process of preparing the site for the trial can begin, including obtaining local ethics and regulatory approvals, development of budgets and contracts, procurement of required trial supplies and insurances, and completion of site refurbishments. Trial staff, such as principal investigators, sub-investigators, pharmacists, nurses, and trial coordinators need to be identified and trained before the trial can be initiated. These obligatory activities are time-consuming and processes vary from country to country, adding further complication and a significant challenge to timely trial implementation. Finally, it is essential to establish collaborative relationships with key stakeholders including the national TB program, regulatory authorities, and advocacy groups.
TREAT TB’s MDR-TB clinical trial capacity building webinar series will continue over the coming months, with webinars scheduled for September, November, January, March, and May. Future topics to be addressed include regulatory requirements, institutional review boards and ethics approval, pharmacy and supply chain management, laboratory strengthening and community engagement among others.
¹ Horsburgh CR, Rusen ID, Mitnick CD. Optimizing MDR-TB clinical trials: insights from the first global MDR-TB Clinical Trials Landscape Meeting. Int J Tuberc Lung Dis. 2016; 20(12):1–3. doi: 10.5588/ijtld.16.0568