One-fourth of the world’s population is infected with tuberculosis (TB). About 10.4 million people, including 1 million children, became ill with TB and 1.7 million died from TB infection in 2016.
Twenty years ago the Centers for Disease Control and Prevention created the Tuberculosis Trials Consortium (TBTC) to study the diagnosis, clinical management, and prevention of TB infection and disease. The TBTC also promotes research within local TB control programs, provides a forum for international collaborative research, and more.
The consortium has 8 medical centers in the U.S. and 8 sites in China, Kenya, Peru, South Africa, Spain, Uganda, and Vietnam.
Westat supports the TBTC by preparing documents used to execute the study, conducting site monitoring visits to ensure compliance with federal regulations and the study protocol, and training site staff on implementing the study.
- We handle the following tasks:
- Conduct site monitoring visits to the TBTC sites twice a year, review the participants’ study records, and ensure that the studies are being implemented according to TBTC protocols and federal regulations
- Assist in developing protocols, procedures, and related materials
- Conduct protocol education and train site staff
- Help manage the TBTC website
- TBTC clinical trials have enrolled more than 14,000 patients and volunteers over the past 20 years.
- The pipeline of new anti-TB drug candidates is the most promising in 40 years, and advances in TB clinical trials have helped boost these drugs.
- Fewer people are falling ill with TB each year, although the numbers are declining very slowly.
- TBTC research has shown that the U.S. Food and Drug Administration needs a shortened TB treatment regime and a more effective and affordable process for approving new TB drugs.