As new therapeutic agents for tuberculosis (TB) become available, there is an urgency to generate evidence for optimal treatment options, particularly for multidrug-resistant tuberculosis (MDR-TB). It is essential that we develop research infrastructure and build capacity for clinical trials in the field in order to generate reliable data to inform policy and guide decision-making. At the recent Union World Conference on Lung Health, TREAT TB’s symposium: Clinical trial capacity building to address multidrug-resistant tuberculosis: challenges and the way forward brought together experts to discuss challenges faced in key areas of research infrastructure, share experiences from past and ongoing studies, and propose solutions.
During the symposium, experts discussed the current landscape for TB clinical trials, focusing on key issues currently affecting clinical trial capacity. Speakers from around the world addressed topics ranging from supply chain management to mycobacteriology laboratory capacity to community engagement in MDR-TB clinical trials. They highlighted progress to date, current challenges and possible ways to improve capacity for conducting clinical trials, drawing on their experience with the STREAM Clinical Trial and other TB research ongoing in their countries.
Dr. Abraham Assefa, from the Armauer Hansen Research Institute, discussed the often-lengthy regulatory review and approval process for clinical trials, which can delay implementation of research that is critical to improving TB management. He highlighted the urgent need to strengthen the capacity of national ethics committees, particularly given the increasing number of clinical trials being conducted in African countries.
During his presentation, Dr. Jan Komrska, Senior Pharmacist at Vital Strategies, shared lessons learned from the STREAM Clinical Trial, highlighting the requirements of Good Clinical Practice as they affect drug supply and management for TB clinical trials. He emphasized the impact of these requirements on facilities, processes and people, and recommended that trial implementers consider the need for continuing education for trial pharmacists, and the practicalities of maintaining temperature-controlled environments for trial drugs.
Dr. Gomathi from the National Institute for Research in Tuberculosis (NIRT), India, presented the main challenges faced by site laboratories in strengthening their physical and human resource capacity to carry out clinical trials. She provided an insight into NIRT’s experience as a supranational reference laboratory and stressed the importance of good standard operating practices and maintaining trial documentation.
Finally, Ezio Tavora Dos Santos Filho, the STREAM Community Engagement Coordinator from REDE-TB, stressed the importance of community engagement, stating that community engagement is a ‘mechanism of accountability’ to ensure that trials and study teams are held accountable to governments, donors, and above all, trial participants. Community engagement is an ethical obligation for all TB clinical trials, but can be overlooked by trial implementers. This represents a missed opportunity to establish a dialogue and relationship of trust between trial implementers and affected communities.
Following the presentations, participants and speakers engaged in a question and answer session, during which Dr I.D. Rusen, Senior Vice President Research and Development, Vital Strategies raised the issue of funding. All too often, funding is tied to a specific clinical trial and does not allow for capacity building to be carried out prior to trial implementation. He pointed out the need for funding to be available for capacity building independently of clinical trials, in order to guarantee sufficient infrastructure and capacity when clinical trials are implemented.
A key focus of TREAT TB is to build capacity in high burden countries to conduct high-quality research independently. As part of TREAT TB, The Union and Vital Strategies have trained health professionals at all STREAM trial sites, and as part of TREAT TB’s operational research program training has also been carried out in countries including Peru and the Philippines.
The STREAM trial has invested significant resources to increase research literacy and TB awareness in affected communities as part of the trial’s community engagement activities. TREAT TB has produced free online educational resources, including an interactive e-tool, Introduction to Operational Research, which provides health practitioners and researchers with a foundational overview of operational research concepts and practices. In addition, TREAT TB has developed Community Engagement training materials and a pharmacy Good Clinical Practice course. In July 2018, TREAT TB launched a webinar series to strengthen capacity to conduct high quality MDR-TB clinical trials. To learn more about the capacity building work that TREAT TB does around the world, click here.
Find the presentations from this session, here.