Positive and negative AIT trials: What makes the difference?
Allergen immunotherapy has proven to be efficacious in allergic rhinitis and asthma. However, results from randomised clinical trials may vary substantially. Clinical trials may unexpectedly fail. The purpose of this review is to discuss the possible factors that may contribute to a successful or unsuccessful study.
Descriptive review exploring the possible causes of negative outcomes in allergen immunotherapy trials.
A series of factors may lead to negative results. Among of these are underpowering of the study, low allergen content in tested extracts, insufficient allergen exposure during monitoring and recruitment of inappropriate patients. In addition, the choice of the primary endpoint may be critical.
A clinical trial aims to evaluate the efficacy of an agent. However, studies with potential effective compounds may fail because of methodical issues. Sometimes, they are the cause of discrepancies between successful phase II and unsuccessful phase III trials. To understand more about failure of studies, investigators and editors should be encouraged to publish negative trials.
Schlüsselwörterallergen immunotherapy randomised clinical trial endpoints negative study phase II trial phase III trial
Consolidated standards of reporting trials
Grass SLIT tablet asthma prevention
House dust mite
Preventive allergy treatment
Randomised clinical trial
Randomised controlled trial
Total combined symptom score
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