An estimated 10.4 million new tuberculosis (TB) cases occurred worldwide in 2015. Unfortunately, the capacity to conduct high-quality TB research is not well developed in the countries that are most severely affected by the disease, including China.

FHI 360 began the China Tuberculosis Clinical Trials Consortium to improve TB studies in that country as researchers struggled to obtain consistent quality data. Since 2013, this consortium has worked to develop a TB clinical trials research platform that meets international standards and is thus able to enroll participants in global, multicenter studies designed to address major gaps in TB knowledge.

The consortium developed a quality management system that includes standard operating procedures and minimum standards for conducting clinical trials. The consortium also provided multiple sites across China with training on good clinical practice guidelines, on establishing reliable and accurate TB laboratory services and on ensuring high-quality data collection. For example, consortium teams led a series of comprehensive trainings and scientific webinars, for local TB investigators, on good clinical laboratory practice, human research ethics, biostatistics and data management. Teams also conducted in-depth assessments of 10 consortium sites to evaluate their preparedness to conduct a clinical trial in compliance with the International Conference on Harmonization, Good Clinical Practice standards.

Several top-performing project sites now have the expertise to participate in two significant opportunities. A global trial will evaluate the effectiveness of new regimens for treating multidrug-resistant TB. This clinical trial is multicenter, parallel-group, open-label, randomized and controlled. A study to shorten treatment regimens, funded by the Chinese government, will focus on patients that have drug-sensitive TB.

The consortium’s leadership team successfully established a framework for management teams that now includes a functioning, Chinese-led scientific review committee and consortium laboratory committee. Using this framework, management teams are now able to set scientific priorities and understand the value of consistent research quality. The leadership team also established bylaws and mechanisms that guide network operations, including the consortium’s board, secretariat, expert group, scientific steering committee and an external technical support and evaluation team. In addition, consortium hospitals can now regularly communicate with each other thanks to the successful launch of a WeChat group and a consortium website that houses relevant guidelines, documents, references and training materials.

The consortium began in 12 sites and now works in 19 sites across China. FHI 360 will continue to hold trainings, conduct assessments and expand the consortium’s network of research sites so that more sites can provide the rigorous support needed to conduct high-quality TB clinical trials. Though it will take years for the consortium and network sites to mature fully, FHI 360’s partnership with the consortium’s leadership is ready to help fill gaps in TB knowledge worldwide.

---

Photo credit: Jessica Scranton/FHI 360