CDC/NIH Workshop. Tuberculosis biomarker and surrogate endpoint research roadmap

Am J Respir Crit Care Med. 2011 Oct 15;184(8):972-9. doi: 10.1164/rccm.201105-0827WS.

Abstract

The Centers for Disease Control and Prevention and National Institutes of Health convened a multidisciplinary meeting to discuss surrogate markers of treatment response in tuberculosis. The goals were to assess recent surrogate marker research and to provide specific recommendations for (1) the qualification and validation of biomarkers of treatment outcome; (2) the standardization of specimen and data collection for future clinical trials, including a minimum set of samples and collection time points; and (3) the creation ofa specimen repository to support biomarker testing. This article summarizes these recommendations and provides a roadmap for their implementation.

Publication types

  • Consensus Development Conference, NIH
  • Guideline
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antitubercular Agents / therapeutic use
  • Biological Specimen Banks
  • Biomarkers / analysis*
  • Biomarkers / metabolism
  • Clinical Trials as Topic / standards*
  • Humans
  • Specimen Handling / standards*
  • Treatment Outcome
  • Tuberculosis* / drug therapy
  • Tuberculosis* / genetics
  • Tuberculosis* / immunology
  • Tuberculosis* / metabolism

Substances

  • Antitubercular Agents
  • Biomarkers