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Tuberculosis Trials Consortium (TBTC): History										Related Pages
										Early TB Clinical TrialsSince the 1940s, the U.S. Public Health Service (USPHS), and the U.S. Department of Veterans Affairs have conducted studies of anti-TB drugs; many of the agents studied are still in use today.
In the 1960s, the USPHS TB control and clinical research programs were transferred to CDC from the National Institutes of Health in Maryland. At this time, CDC began a series of clinical trials of rifampin that, in follow-up to key trials conducted by the British Medical Research Council, the British Thoracic Association, and others, helped to establish the efficacy and safety of rifampin-based, 6-month, short-course outpatient therapy for TB.  By comparison, before rifampin became available, TB patients in the late 1950s and early 1960s were treated for 18-24 months, part of it in-hospital, to achieve high rates of cure.TB Resurgence Leads to Increased Support for TB ProgramsIn the 1980s, when declining rates of TB in the United States led to declining TB funding, and when shorter course treatments were being increasingly adopted, federal support for TB control efforts diminished. Such was the lack of support for CDC’s clinical trials program that a key CDC trial (USPHS Study 21, which confirmed for U.S. TB programs the efficacy of 6-month short-course therapy) was nearly terminated for lack of adequate funding.
As a result of the resurgence of TB in the United States in the late 1980s and early 1990s, and of the outbreaks of multiple-drug-resistant TB in hospitals and correctional facilities, federal support for TB control was greatly increased in 1992.Creation of TBTCIn 1993-94, CDC announced a competitive solicitation to fund a group of TB researchers and sites capable of conducting TB clinical trials; successful applicants were funded for a period of 5 years (1993–1998). CDC selected sites that:
provided access to significant numbers of TB patients,
had experience with clinical trials,
demonstrated qualifications of the trial team, and
submitted robust plans for recruitment, management, and follow-up of patients.Planning together, the researchers and CDC decided to conduct first a randomized, clinical trial  comparing a once-weekly, rifapentine-based, continuation-phase regimen to the then-standard, twice-weekly, rifampin-based “Denver” regimen, both given for the last 4 months of the 6-month treatment for TB. This trial, called USPHS Study 22, began in 1995, enrolled 1,075 TB patients from the United States and Canada, and reported final results in 2002.
In 1997-98, CDC and the Study 22 investigators reorganized their collaboration as a structured consortium, creating the TBTC with the adoption of formal by-laws in 1998. The bylaws were updated in 2012 and again in 2021.
**TBTC 1999-2009**
In 1999, the TBTC underwent its second competitive process to select the clinical trial sites that would comprise the TBTC during 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.
**TBTC: 2010-2020**
In 2009, the TBTC underwent its third re-competition. During 2010–2020, TBTC’s international presence expanded from a few clinical study sites located outside of North America, to sites in Peru, Spain, South Africa (two sites), Uganda, Kenya, Vietnam, and China (Hong Kong). The TBTC 2010–2020 also included U.S. sites in New York, Washington DC, Texas (four sites), Colorado, and Tennessee.
**TBTC: 2021-2030 and Beyond**
In March 2021, CDC announced the sites for the research cycle through December 2030.
TBTC clinical trials have enrolled more than 16,000 patients and volunteers over the past 20 years. The consortium’s annual operating budget is approximately $11,000,000.00. Confronting the many challenges to the successful development of new TB drugs and treatment regimens, the TBTC looks forward with optimism.
							
					
						Page last reviewed:  June 23, 2021										Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


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