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How to do a clinical trial? Recommendations from the aerobiological point of view

Katharina Bastl1, Maximilian Bastl1, Karl-Christian Bergmann2

  • 1Aerobiology and Pollen Information Research Unit, Department of Oto-Rhino-Laryngology, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.

The World Allergy Organization Journal
|April 13, 2019
PubMed
Abstract

Insights

High-quality pollen data and forecasts are crucial for reliable allergy immunotherapy clinical trials. This study introduces methods for data validation and planning to improve scientific standards in aerobiology research.

Area of Science:

  • Aerobiology
  • Clinical Trial Design
  • Allergy Research

Background:

  • Allergy immunotherapy is the only long-term treatment for pollen allergy.
  • Clinical trials require validated, high-quality pollen data and forecasts for comparability and scientific rigor.
  • The aerobiological component of clinical trials has lacked standardized definition and data utilization.

Purpose of the Study:

  • To present a novel method for pollen data replacement during monitoring station failures.
  • To provide recommendations for the ideal planning of the aerobiological aspects of pollen allergy clinical trials.
  • To develop a checklist for managing the aerobiological components of clinical trials.

Main Methods:

  • Utilized pollen data from eight Austrian monitoring stations as an example.
  • Applied Gower's similarity for objective calculation of data replacement based on time frame and specific aeroallergens (birch, grass, mugwort, ragweed).
  • Detailed planning strategies for site selection, data acquisition, pollen season definition, and risk management.

Main Results:

  • A method for pollen data replacement using Gower's similarity was demonstrated.
  • Recommendations for optimal aerobiological planning in clinical trials were established.
  • A comprehensive checklist for aerobiological trial components was developed.

Conclusions:

  • Virtual biogeographic regions offer objective establishment and integration into clinical trials.
  • Pollen data and forecast data are distinct and require critical evaluation by trained aerobiologists.
  • Institutions with aerobiological expertise, preferably ISO-certified, should manage these tasks in clinical trials.
Keywords:
AIT, Allergy ImmunotherapyAPIn, annual pollen indexAerobiologyAllergen immunotherapyChecklistClinical trialsEAACI, European Academy of Allergy and Clinical ImmunologyEAN, European Aeroallergen Network (https://ean.polleninfo.eu/Ean)MPS, main pollen seasonPHD, Patient's Hayfever Diary (www.pollendiary.com)Pollen dataSPIn, seasonal pollen index

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