ArticleThe World Allergy Organization journal2019
How to do a clinical trial? Recommendations from the aerobiological point of view.
Article in The World Allergy Organization journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Common Allergens and Immune Responses Associated with Allergic Rhinitis in China.Journal of asthma and allergy · 2023Review
- Real-world data using mHealth apps in rhinitis, rhinosinusitis and their multimorbidities.Clinical and translational allergy · 2022Article
- Aerobiological monitoring in a desert type ecosystem: Two sampling stations of two cities (2017-2020) in Qatar.PloS one · 2022Article
- Dogmas, challenges, and promises in phase III allergen immunotherapy studies.The World Allergy Organization journal · 2021Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAllergy immunotherapy is still the only treatment of pollen allergy, providing a long-term effect. Clinical trials with pollen allergic patients are in need of validated, high quality pollen data and forecasts in order to grant comparability and to adhere to scientific standards. The aerobiological part of clinical trials remained hitherto not well defined, leaving the definition and use of pollen and forecast data more or less open.
methodsPollen data of eight Austrian pollen-monitoring stations were selected and used as an example to present a new method of pollen data replacement, in case of station failure. Gower's similarity provides an objective calculation based on a defined time frame and a specific aeroallergen (for example birch, grass, mugwort and ragweed).
resultsThe ideal planning of the aerobiological part of a clinical trial with a pollen extract is described in detail with specific recommendations concerning site selection, pollen and forecast data, definition of the pollen season, and risk management. A checklist for every clinical trial with an aerobiological part was developed.
conclusionVirtual biogeographic regions are beneficial due to their objective establishment, and can be integrated into clinical trials. Pollen data is not the same as forecast data. Both datasets have to be critically evaluated by trained aerobiologists before they are used in clinical trials. Therefore, only institutions with aerobiological knowledge, at best ISO-certified, should be involved in clinical trials and handle the aerobiological tasks.
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