Thank you for your interest in our program
The unique mission of the CDRC is to provide data early in the developmental pipeline on the performance of investigational diagnostics and their potential impact on TB management algorithms in endemic countries.
The CDRC is currently accepting applications. These applications are directed at technology holders who seek to have their diagnostic evaluated by the CDRC at one of our four clinical study sites.
In general, technologies that are well-suited for CDRC studies are those that:
- Have potential to impact TB diagnostic algorithms in endemic settings
- Have existing proof-of-principle data but have not undergone extensive field testing
Studies that CANNOT be performed through the CDRC are:
- Interventional studies (i.e. studies in which the result of an investigational test is used for individual patient clinical decision-making)
- The development of diagnostics
Those applying to our program can expect constructive feedback and advice about whether or not the diagnostic is appropriate for consideration by the CDRC, as well as any refinements that may be necessary before studies can begin.
The selection process involves:
- A first level of review of concept sheets by members of the CDRC Steering Committee comprised of CDRC leadership, and the NIAID. Each concept sheet will have a primary and secondary reviewer and will be read by all members.
- Steering Committee members then will be assigned to present each concept sheet to the Executive Committee. The Executive Committee will prioritize concept sheets for implementation pending review by the Steering Committee of response to issues that arise.
- The External Scientific Advisory Group (ESAG) will provide a second level of review for concept sheets that are recommended for implementation. For concept sheets that are given highest priority in the initial review process, the applicant will be contacted by the CDRC and a brief presentation (web conference) to the Steering Committee will be requested.
- The proposed diagnostic will then undergo a second level of review and prioritization by members of the Executive Committee and the NIH. Decisions concerning selection will be announced within 4 months of concept sheet submission.
Continue to the Review and Prioritization of Concept Sheets