Rhinosinusitis: Developing guidance for clinical trials-Reference-Cited by-同舟云学术

Rhinosinusitis: Developing guidance for clinical trials

Published:2006-11 Issue:5_suppl Volume:135 Page:S31-S80
ISSN:0194-5998
Container-title:Otolaryngology–Head and Neck Surgery
language:en
Short-container-title:Otolaryngol Head Neck Surg

Author:

Meltzer Eli O.¹,Hamilos Daniel L.²,Hadley James A.³,Lanza Donald C.⁴,Marple Bradley F.⁵,Nicklas Richard A.⁶,Adinoff Allen D.⁷,Bachert Claus⁸,Borish Larry⁹,Chinchilli Vernon M.¹⁰,Danzig Melvyn R.¹¹,Ferguson Berrylin J.¹²,Fokkens Wytske J.¹³,Jenkins Stephen G.¹⁴,Lund Valerie J.¹⁵,Mafee Mahmood F.¹⁶,Naclerio Robert M.¹⁷,Pawankar Ruby¹⁸,Ponikau Jens U.¹⁹,Schubert Mark S.²⁰,Slavin Raymond G.²¹,Stewart Michael G.²²,Togias Alkis²³,Wald Ellen R.²⁴,Winther Birgit²⁵

Affiliation:

1. Allergy and Asthma Medical Group and Research Center Department of Pediatrics, University of California, San Diego, San Diego, California (Dr Meltzer);, Department of Medicine, University of Arizona, Phoenix and Tucson, Allergy Asthma Clinic LTD, Phoenix, Arizona

2. Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, Massachusetts (Dr Hamilos);

3. Department of Otolaryngology, University of Rochester Medical Center, Rochester, New York (Dr Hadley);

4. Sinus and Nasal Institute of Florida, PA, St Anthony's Carillon Outpatient and Wellness Center, St Petersburg, Florida (Dr Lanza);

5. Department of Otolaryngology, UT Southwestern Medical Center, Dallas, Texas (Dr Marple);

6. Department of Medicine, George Washington Medical Center, Washington, DC (Dr Nicklas);

7. Department of Pediatrics and Pharmacology, University of Colorado Health Sciences, Denver, Colorado (Dr Adinoff);

8. ENT Clinic, University Hospital, Ghent, Belgium (Dr Bachert);

9. Department of Medicine, Asthma and Allergic Diseases Center, University of Virginia Health System, Charlottesville, Virginia (Dr Borish);

10. Department of Health Evaluation Science, Penn State College of Medicine, Hershey, Pennsylvania (Dr Chinchilli);

11. Distinguished Clinical Research Fellow, Schering Plough Research Institute, Kenilworth, NJ (Dr Danzig);

12. Division of Sino-nasal Disorder and Allergy, Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (Dr Ferguson);

13. ENT Department, Academic Medical Centre Hospital, University of Amsterdam, Amsterdam, The Netherlands (Dr Fokkens);

14. Clinical Microbiology Laboratories, Mount Sinai Medical Center, New York, New York (Dr Jenkins);

15. Department of Rhinology, University College London, London, United Kingdom (Dr Lund);

16. Department of Radiology, University of California, San Diego, San Diego, California (Dr Mafee);

17. Department of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, Illinois (Dr. Naclerio);

18. Nippon Medical School, Tokyo, Japan (Dr Pawankar);

19. University of Buffalo (The State University of New York) Buffalo, New York (Dr Ponikau);

20. Department of Medicine, University of Arizona, Phoenix and Tucson, Allergy Asthma Clinic LTD, Phoenix, Arizona

21. Department of Internal Medicine, St Louis University School of Medicine, St Louis, Missouri

22. Department of Otolaryngology, Weill Cornell Medical College, New York, New York (Dr Stewart);

23. Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland (Dr Togias);

24. Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin (Dr Wald);

25. Department of Otolaryngology, University of Virginia Health System, Charlottesville, Virginia.

Abstract

The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication, “Rhinosinusitis: Establishing definitions for clinical research and patient care” and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

Publisher

SAGE Publications

Subject

Otorhinolaryngology,Surgery

Link

http://journals.sagepub.com/doi/pdf/10.1016/j.otohns.2006.09.014

Reference150 articles.

1. EAACI Position Paper on Rhinosinusitis and Nasal Polyps Executive Summary

2. US Food and Drug Administration.Title 21 Code of Federal Regulations. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm. Accessed June 1, 2006.

3. FDA: Evidentiary standards for drug development and approval

4. Biomarkers and surrogate markers: An FDA perspective

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