How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement

Bousquet, J. et al. (2011) How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement. Allergy, 66(6), pp. 765-774. (doi:10.1111/j.1398-9995.2011.02590.x)

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Publisher's URL: http://dx.doi.org/10.1111/j.1398-9995.2011.02590.x

Abstract

Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom–medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCT

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Briggs, Professor Andrew
Authors: Bousquet, J., Sch, H.J., Bousquet, P.J., Bachert, C., Canonica, G.W., Durham, S., Carlsen, K.-H., Malling, H.-J., Simons, F.E.R., Anto, J., Baena-Cagnani, C.E., Bergmann, K.-C., Bieber, T., Briggs, A.H., Brozek, J., Calderon, M.A., Dahl, R., Devillier, P., Gerth van Wijk, R., Howarth, P., Larenas, D., Papadopoulos, N.G., Schmid-Grendelmeier, P., and Zuberbier, T.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
Journal Name:Allergy
ISSN:0105-4538
ISSN (Online):1398-9995
Published Online:18 April 2011
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