Literature DB >> 21737585

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

Payam Nahid1, Jussi Saukkonen, William R Mac Kenzie, John L Johnson, Patrick P J Phillips, Janet Andersen, Erin Bliven-Sizemore, John T Belisle, W Henry Boom, Annie Luetkemeyer, Thomas B Campbell, Kathleen D Eisenach, Richard Hafner, Jeffrey L Lennox, Mamodikoe Makhene, Susan Swindells, M Elsa Villarino, Marc Weiner, Constance Benson, William Burman.   

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.

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Year:  2011        PMID: 21737585      PMCID: PMC3208659          DOI: 10.1164/rccm.201105-0827WS

Source DB:  PubMed          Journal:  Am J Respir Crit Care Med        ISSN: 1073-449X            Impact factor:   21.405


  29 in total

1.  American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis.

Authors:  Henry M Blumberg; William J Burman; Richard E Chaisson; Charles L Daley; Sue C Etkind; Lloyd N Friedman; Paula Fujiwara; Malgosia Grzemska; Philip C Hopewell; Michael D Iseman; Robert M Jasmer; Venkatarama Koppaka; Richard I Menzies; Richard J O'Brien; Randall R Reves; Lee B Reichman; Patricia M Simone; Jeffrey R Starke; Andrew A Vernon
Journal:  Am J Respir Crit Care Med       Date:  2003-02-15       Impact factor: 21.405

Review 2.  Early clinical development of anti-tuberculosis drugs: science, statistics and sterilizing activity.

Authors:  Geraint R Davies
Journal:  Tuberculosis (Edinb)       Date:  2010-04-10       Impact factor: 3.131

3.  Statistical validation of intermediate endpoints for chronic diseases.

Authors:  L S Freedman; B I Graubard; A Schatzkin
Journal:  Stat Med       Date:  1992-01-30       Impact factor: 2.373

Review 4.  Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice.

Authors:  Robert S Wallis; Madhukar Pai; Dick Menzies; T Mark Doherty; Gerhard Walzl; Mark D Perkins; Alimuddin Zumla
Journal:  Lancet       Date:  2010-05-18       Impact factor: 79.321

5.  Surrogate endpoints in clinical trials: definition and operational criteria.

Authors:  R L Prentice
Journal:  Stat Med       Date:  1989-04       Impact factor: 2.373

6.  Assessment of new sterilizing drugs for treating pulmonary tuberculosis by culture at 2 months.

Authors:  D A Mitchison
Journal:  Am Rev Respir Dis       Date:  1993-04

7.  Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

Authors:  V G De Gruttola; P Clax; D L DeMets; G J Downing; S S Ellenberg; L Friedman; M H Gail; R Prentice; J Wittes; S L Zeger
Journal:  Control Clin Trials       Date:  2001-10

Review 8.  Immunological biomarkers of tuberculosis.

Authors:  Gerhard Walzl; Katharina Ronacher; Willem Hanekom; Thomas J Scriba; Alimuddin Zumla
Journal:  Nat Rev Immunol       Date:  2011-04-08       Impact factor: 53.106

9.  Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.

Authors:  William R Mac Kenzie; Charles M Heilig; Lorna Bozeman; John L Johnson; Grace Muzanye; Denise Dunbar; Kenneth C Jost; Lois Diem; Beverly Metchock; Kathleen Eisenach; Susan Dorman; Stefan Goldberg
Journal:  PLoS One       Date:  2011-04-11       Impact factor: 3.240

10.  Bactericidal and sterilizing activities of antituberculosis drugs during the first 14 days.

Authors:  Amina Jindani; Caroline J Doré; Denis A Mitchison
Journal:  Am J Respir Crit Care Med       Date:  2003-01-06       Impact factor: 21.405

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  34 in total

1.  High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial.

Authors:  Susan E Dorman; Payam Nahid; Ekaterina V Kurbatova; Stefan V Goldberg; Lorna Bozeman; William J Burman; Kwok-Chiu Chang; Michael Chen; Mark Cotton; Kelly E Dooley; Melissa Engle; Pei-Jean Feng; Courtney V Fletcher; Phan Ha; Charles M Heilig; John L Johnson; Erica Lessem; Beverly Metchock; Jose M Miro; Nguyen Viet Nhung; April C Pettit; Patrick P J Phillips; Anthony T Podany; Anne E Purfield; Kathleen Robergeau; Wadzanai Samaneka; Nigel A Scott; Erin Sizemore; Andrew Vernon; Marc Weiner; Susan Swindells; Richard E Chaisson
Journal:  Contemp Clin Trials       Date:  2020-01-22       Impact factor: 2.226

2.  Need for rigor in design, reporting, and interpretation of transcriptomic biomarker studies.

Authors:  N D Walter; L Bemis; M Edwards; A R Ovrutsky; E D Chan
Journal:  J Clin Microbiol       Date:  2012-12       Impact factor: 5.948

Review 3.  Advances in the development of new tuberculosis drugs and treatment regimens.

Authors:  Alimuddin Zumla; Payam Nahid; Stewart T Cole
Journal:  Nat Rev Drug Discov       Date:  2013-05       Impact factor: 84.694

Review 4.  Translating basic science insight into public health action for multidrug- and extensively drug-resistant tuberculosis.

Authors:  Nicholas D Walter; Michael Strong; Robert Belknap; Diane J Ordway; Charles L Daley; Edward D Chan
Journal:  Respirology       Date:  2012-07       Impact factor: 6.424

5.  Transcriptional Adaptation of Drug-tolerant Mycobacterium tuberculosis During Treatment of Human Tuberculosis.

Authors:  Nicholas D Walter; Gregory M Dolganov; Benjamin J Garcia; William Worodria; Alfred Andama; Emmanuel Musisi; Irene Ayakaka; Tran T Van; Martin I Voskuil; Bouke C de Jong; Rebecca M Davidson; Tasha E Fingerlin; Katerina Kechris; Claire Palmer; Payam Nahid; Charles L Daley; Mark Geraci; Laurence Huang; Adithya Cattamanchi; Michael Strong; Gary K Schoolnik; John Lucian Davis
Journal:  J Infect Dis       Date:  2015-03-11       Impact factor: 5.226

6.  Circulating biomarkers of pulmonary and extrapulmonary tuberculosis in children.

Authors:  Nathella Pavan Kumar; R Anuradha; Bruno B Andrade; N Suresh; R Ganesh; Janani Shankar; V Kumaraswami; Thomas B Nutman; Subash Babu
Journal:  Clin Vaccine Immunol       Date:  2013-03-13

7.  RePORT International: Advancing Tuberculosis Biomarker Research Through Global Collaboration.

Authors:  Carol D Hamilton; Soumya Swaminathan; Devasahayam J Christopher; Jerrold Ellner; Amita Gupta; Timothy R Sterling; Valeria Rolla; Sudha Srinivasan; Muhammad Karyana; Sophia Siddiqui; Sonia K Stoszek; Peter Kim
Journal:  Clin Infect Dis       Date:  2015-10-15       Impact factor: 9.079

8.  A Blueprint to Address Research Gaps in the Development of Biomarkers for Pediatric Tuberculosis.

Authors:  Mark Patrick Nicol; Devasena Gnanashanmugam; Renee Browning; Eleanor S Click; Luis E Cuevas; Anne Detjen; Steve M Graham; Michael Levin; Mamodikoe Makhene; Payam Nahid; Carlos M Perez-Velez; Klaus Reither; Rinn Song; Hans M L Spiegel; Carol Worrell; Heather J Zar; Gerhard Walzl
Journal:  Clin Infect Dis       Date:  2015-10-15       Impact factor: 9.079

Review 9.  Assessment of treatment response in tuberculosis.

Authors:  Neesha Rockwood; Elsa du Bruyn; Thomas Morris; Robert J Wilkinson
Journal:  Expert Rev Respir Med       Date:  2016-03-31       Impact factor: 3.772

10.  Aptamer-based proteomic signature of intensive phase treatment response in pulmonary tuberculosis.

Authors:  Payam Nahid; Erin Bliven-Sizemore; Leah G Jarlsberg; Mary A De Groote; John L Johnson; Grace Muzanyi; Melissa Engle; Marc Weiner; Nebojsa Janjic; David G Sterling; Urs A Ochsner
Journal:  Tuberculosis (Edinb)       Date:  2014-02-07       Impact factor: 3.131

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