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Related Experiment Video

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Examination of Thymic Positive and Negative Selection by Flow Cytometry
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Positive and negative AIT trials: What makes the difference?

Roy Gerth van Wijk1

  • 1Section of Allergology, Department of Internal Medicine, Erasmus Medical Centre, 's Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.

Allergo Journal International
|September 18, 2018
PubMed
Summary
This summary is machine-generated.

Allergen immunotherapy trials for allergic rhinitis and asthma can fail due to methodological issues. Factors like study power, allergen dose, patient selection, and endpoint choice significantly impact clinical trial outcomes.

Keywords:
Allergen immunotherapyEndpointsNegative studyPhase II trialPhase III trialRandomised clinical trial

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Area of Science:

  • Allergy and Immunology
  • Clinical Trial Methodology

Background:

  • Allergen immunotherapy is effective for allergic rhinitis and asthma.
  • Clinical trial results can vary, and studies may unexpectedly fail.

Purpose of the Study:

  • To discuss factors contributing to successful or unsuccessful allergen immunotherapy clinical trials.
  • To identify reasons for discrepancies between different trial phases.

Main Methods:

  • Descriptive review of potential causes for negative outcomes in allergen immunotherapy trials.

Main Results:

  • Negative outcomes can result from underpowering, low allergen content, insufficient allergen exposure, inappropriate patient recruitment, and critical endpoint selection.

Conclusions:

  • Methodological issues can cause trials of effective compounds to fail, leading to discrepancies between Phase II and Phase III results.
  • Publication of negative trials is encouraged to better understand study failures.