Tuberculosis Trials Consortium (TBTC)

Background

Since the 1940s the U.S. Public Health Service (USPHS), and the Department of Veterans Affairs have been part of TB control history because of their role in conducting drug studies for all anti-TB drugs still in use today. In 1960, the USPHS TB control and clinical research program was transferred to CDC from the National Institutes of Health in Maryland. At this time, the CDC began a series of clinical trials of rifampin that helped establish the recommendations for 6 month short-course outpatient therapy for TB. By comparison, TB patients in the early 1960s and before rifampin, had to endure treatment for 18-24 months, part of it in a hospital, and had to take an imposing total of over 600 doses of medication.

In the 1980s, when a declining TB trend led to declining TB funding, and shorter treatment had become the norm, support for TB drug trials slowed. Such was the lack of support for CDC’s clinical trials program that one of CDC’s studies (USPHS Study 21) was nearly terminated several times for lack of adequate funding. With the resurgence of TB, federal support for TB control was restored in the early 1990s. In 1993, CDC conducted the first open competition for a group of TB researchers whose study sites were capable of conducting TB clinical trials, and proceeded to fund them for a period of 5 years (1993–1998). CDC chose sites that met strict readiness criteria: access to TB patients, experience with clinical trials, demonstrated qualifications of the clinical team, and a good plan for recruitment, management, and follow-up of patients. The researchers and CDC decided to conduct first a randomized clinical trial comparing a once-weekly rifapentine-based regimen against the standard twice-weekly rifampin-based regimen, given after the first 2 months of intensive treatment for TB. This trial became USPHS-TBTC Study 22, the first clinical trial conducted by the TBTC: 1,075 TB patients from the US and Canada volunteered as participants.

In 1997 CDC and the investigators from the funded study sites formalized their collaboration, and the TBTC was thus officially created, with formal by-laws adopted in 1998. Several working committees were established. One committee (Core Science Group) develops the scientific program of research, a second (Implementation and Quality Group) supervises the conduct and quality of ongoing studies, and a third (External Relations Group) represents the TBTC to outside entities. The Executive Affairs Group serves as the executive arm of the Steering Committee. The Data Coordinating Center of the TBTC is housed in the Clinical and Health Systems Research Branch of CDC’s Division of Tuberculosis Elimination (DTBE). The TBTC CDC team is composed of medical officers, epidemiologists, trialist, data analysts, data managers, programmers, data clerks, multiple public health students and various administrative support staff, including an administrator for Institutional Review Board approvals.

In 1999 the TBTC underwent its second formal competitive process, to select the clinical trial sites that would comprise the TBTC during the most recent period of CDC-funded research: 1999–2009. The selection of sites at that time resulted in a consortium of 23 centers located in the United States and Canada. In 2003, the consortium gained an international presence by adding sites in Brazil, Spain, and Sub-Saharan Africa.