Tuberculosis (TB) remains one of the top 10 causes of death worldwide, surpassing both HIV/AIDS and malaria, and it is the leading cause of death from a single infectious agent.1 Further, multidrug-resistant TB (MDR-TB), caused by bacteria that do not respond to the two most effective first-line anti-TB drugs, is considered a serious public health issue.
China Tuberculosis Clinical Trials Consortium (CTCTC)
In 2013, FHI Clinical’s parent company, FHI 360, provided technical support and guidance for clinical trial capacity building for the China Tuberculosis Clinical Trials Consortium (CTCTC). This was initiated by Beijing Chest Hospital (BCH), which also serves as the Clinical Center of Tuberculosis (CCTB) within the Chinese Center for Disease Control (China CDC). Investment was provided by BCH, CTCTC member hospitals and the US National Institutes of Health (NIH). The FHI Clinical team continues to support the consortium, as described in a recent article in the Infectious Diseases of Poverty journal.
Given that China is one of eight countries accounting for two-thirds of new TB cases globally, BCH began the nationwide collaborative clinical trial network with the primary mission to strengthen capacity and attract external funding for TB clinical trials, as well as the following aims:
- Recruit leading hospitals that care for TB patients
- Conduct on-site assessments to identify capacity gaps and need for improvement
- Design and deliver capacity-building activities
- Attract and deliver high-quality results for TB clinical trials
CTCTC sites multiply, expanding coverage
The first 12 TB hospitals included in the CTCTC were chosen because they were already certified by the National Medical Products Administration (NMPA) to conduct TB clinical trials. Since then, the number of sites has increased to 24, covering 20 of China’s 34 provinces. Of these 24 sites, 22 have been accredited by the NMPA to conduct TB clinical trials.
The CTCTC is now considered the largest nationwide collaborative clinical trial network of investigators, ethicists, community members and international partners. Growth has been supported by good leadership, effective international cooperation, local commitment and an improving regulatory environment. For example, to expedite review and approval processes, the NMPA has implemented predictable 60-working-day review periods for applications, now allows data from non-China trials to be used for registration applications, and expedites the review of new drugs for diseases of public health significance such as TB.
To prepare CTCTC sites for contribution to international TB clinical trials, BCH/CCTB worked with the NIAID, NIH and FHI Clinical teams to design a capacity-building package based on three key principles: consider the best international experiences, target the knowledge and skill gaps of the sites, and be sustainable. This training package has been refined based on ongoing site assessments and covers eight domains:
- Scientific knowledge
- International Council for Harmonisation Good Clinical Practice (ICH-GCP)
- Research ethics
- Laboratory processes
- Data management
- Quality management
- Pharmacy management
- Research training and funding for young investigators
CTCTC structure: International collaboration with local support
The CTCTC has three levels of management:
- Board of Directors, led by BCH/CCTB with representatives from each CTCTC member hospital
- Coordination Center, based in BCH/CCTB and responsible for coordinating the CTCTC technical units, member hospitals and partners
- Technical Units: Research Ethics Unit, Training Unit, Scientific Panel, Lab Unit, Quality Control/Monitoring and Evaluation (M&E) Unit
International collaboration has been key to smooth execution of the project, providing access to international TB research laboratory expertise and senior advisors with extensive experience in clinical trial design and implementation. In addition, local CTCTC sites are strongly committed to improving their capacity to conduct clinical trials and actively participate in trainings.
Within the CTCTC network, there are several large-scale domestic trials testing the safety and efficacy of drugs, vaccines and therapeutics for TB. Since 2017, 15 research projects have been selected to receive the CTCTC research grant for young investigators in member hospitals. In addition, the network is preparing to contribute to international, multicenter studies.