Trial Management System for TB Clinical Research

NOTICE OF INTENT TO ISSUE AN ORDER. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC) hereby announces its intent to issue a sole source order to OpenClinca LLC, at 163 Highland Ave, 1173, Needham MA, 02494 for Trial Management System for TB Clinical Research. In 1997 CDC and the investigators from these sites decided to reorganize their activities, creating the TB Trials Consortium, or TBTC.

TBTC is based in the Clinical Research Branch (CRB) of CDC’s Division of Tuberculosis Elimination (DTBE). The CRB includes medical officers, epidemiologists, health scientists, clinical research specialists, laboratorians, data analysts, data managers, statisticians, and contract specialists.

Formal by-laws for TBTC were adopted in 1998, establishing a central Steering Committee, made up of one representative from each site and one from CDC, as well as several executive committees: Core Science Group (CSG); Implementation and Quality Committee (IQC); Publications and Presentations committee (P&P); and Advocacy and External Relations (AER). The purpose of the Steering Committee was to develop a long-term comprehensive scientific agenda for the TBTC.

An Executive Affairs Group (EAG), composed of committee chairs and CRB leadership, was to serve as the executive arm of the Steering Committee, and was responsible for day-to-day decision-making. Current funding has awarded contracts to a new group of TBTC trial sites for the next 10-year cycle, from September 2020 to September 2030. There are also trial sites funded via an interagency agreement with the Veteran’s Administration.

While TBTC data have historically been managed using a custom-built Trial Management system, the functionality of the current system has significant limitations. Modern systems are specifically built for clinical trial data use and are highly adaptable, have more features, and are less expensive than the current system in use. It is the intent of the DTBE that TBTC continue its efforts to conduct therapeutic, diagnostic, and preventive research in support of the CDC goal of TB elimination.

An improved system will provide TBTC clinical trials with a faster, more comprehensive, and responsive system for data intake, trial monitoring, and drug management at less cost, enhancing the TB control program of the United States and the mission of domestic TB elimination. This contract will be for two years.