Tuberculosis Clinical Diagnostics Research Consortium

The Tuberculosis Clinical Diagnostics Research Consortium (CDRC) is an interdisciplinary consortium of scientists, clinicians and support personnel whose mission is to provide data on the performance of investigational diagnostics and their potential impact on TB management algorithms in endemic countries. The project began on September 2009 and was established through a seven-year contract from the NIH/NIAID.

The CDRC has four clinical sites – Infectious Diseases Institute, Kampala, Uganda; University of Cape Town, Cape Town, South Africa; Núcleo de Doenças Infecciosas/Universidade Federal do Espirito Santo, Vitoria, Brazil; and Yonsei University College of Medicine/International Tuberculosis Research Center/National Masan TB Hospital, Seoul, South Korea, and additional collaborators from the Johns Hopkins School of Medicine, Baltimore, MD; the New Jersey Medical School/UMDNJ, Newark, NJ; the Foundation for New and Innovative Diagnostics, Geneva, Switzerland; Imperial College, London, United Kingdom; and Westat, Inc., Rockville, MD.

At these clinical sites, the CDRC will conduct feasibility studies of new diagnostics and provide input back to the technology holder with respect to further development or evaluation. The CDRC will collaborate with other TB research networks and consortia having a common goal of identifying better diagnostic tools and strategies for TB. The Principal Investigator of the CDRC is Dr. Jerrold J. Ellner (Boston Medical Center/Boston University) and the Co-Principal Investigator and Director of Clinical Studies is Dr. Susan Dorman (Johns Hopkins University).

The goal of the CDRC is to provide data relatively early in the developmental pipeline on the performance of investigational diagnostics. This will be accomplished mainly through feasibility studies conducted at one or more of the designated CDRC international study sites. The resulting data will allow for decision-making regarding further development and/or evaluation of these diagnostics.

The CDRC will also inform and advise scientists and manufacturers on further development and refinement of diagnostics that promise to accelerate and improve the accuracy of TB diagnosis and the rapid detection of drug resistance.