Randomized Controlled Trials and Real‐World Evidence in Allergen Immunotherapy: A Critical Reflection on Methodological Paradigms, Ethical Implications, and Industry Influence

Neither RCTs nor RWE, taken in isolation, provide a sufficient picture of the efficacy and safety of AIT. Only an integrated approach, combining methodological rigor and pragmatic relevance, accompanied by independent monitoring of conflicts of interest and greater transparency, can support truly evidence-based medicine.

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Publication Details

Journal
Journal of Evaluation in Clinical Practice
Published
2026-02-01
DOI
https://doi.org/10.1111/jep.70382
Primary Topic
Allergic Rhinitis and Sensitization
Type
article
Field-Weighted Citation Impact
0.00
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article

Randomized Controlled Trials and Real‐World Evidence in Allergen Immunotherapy: A Critical Reflection on Methodological Paradigms, Ethical Implications, and Industry Influence

Marcello Melluso, A. Seidita, Gabriele Di Lorenzo
Journal of Evaluation in Clinical Practice
Allergic Rhinitis and Sensitization
article

Randomized Controlled Trials and Real‐World Evidence in Allergen Immunotherapy: A Critical Reflection on Methodological Paradigms, Ethical Implications, and Industry Influence

Marcello Melluso, A. Seidita, Gabriele Di Lorenzo
article en

Abstract

Neither RCTs nor RWE, taken in isolation, provide a sufficient picture of the efficacy and safety of AIT. Only an integrated approach, combining methodological rigor and pragmatic relevance, accompanied by independent monitoring of conflicts of interest and greater transparency, can support truly evidence-based medicine.

Journal of Evaluation in Clinical PracticeVol. 32(1)
Department of Health (ES), Institute for Biomedical Research and Innovation (IT), University of Palermo (AR), University of Palermo (IT)
Openalex Percentile: Top 60%
Allergic Rhinitis and Sensitization
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