Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce

Specific Immunotherapy for respiratory allergy is used since about one century and there is now solid documentation of its efficacy. Nevertheless, the methods and experimental designs used in clinical trials are quite heterogeneous and there is no unanimously accepted methodological standard. Many s...

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Bibliographic Details
Published in:Allergy 2007-03, Vol.62 (3), p.317-324
Main Authors: Canonica, G.W, Baena-Cagnani, C.E, Bousquet, J, Bousquet, P.J, Lockey, R.F, Malling, H.-J, Passalacqua, G, Potter, P, Valovirta, E
Format: Article
Language:English
Subjects:
clinical trials
Clinical Trials as Topic - standards
Desensitization, Immunologic - standards
Health Planning Guidelines
Humans
Patient Selection
Research Design
Respiratory Hypersensitivity - therapy
subcutaneous immunotherapy
sublingual immunotherapy
Treatment Outcome
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Summary:Specific Immunotherapy for respiratory allergy is used since about one century and there is now solid documentation of its efficacy. Nevertheless, the methods and experimental designs used in clinical trials are quite heterogeneous and there is no unanimously accepted methodological standard. Many studies are planned with study designs that may not confirm the clinical value of SIT as an effective treatment to reduce disease severity. To ensure that patients are treated based on sound scientific evidence and to minimize the risk of misusing limited financial resources for scientific studies, the World Allergy Organization (WAO) convened a group of experts to provide guidelines for the methodology of future immunotherapy studies. This document summarizes the recommendations for study design, patients' selection, appropriate outcomes and statistical treatment to be used in planning and performing clinical trials with specific immunotherapy.
ISSN:0105-4538
1398-9995
0108-1675
DOI:10.1111/j.1398-9995.2006.01312.x