Allergen immunotherapy: the growing role of observational and randomised
trial “real-world evidence”
Abstract
Although there is a considerable body of knowledge about allergen
immunotherapy (AIT), there is a lack of data on the reliability of
real-world evidence (RWE) in AIT and consequently, a lack of information
on how AIT effectively works in real life. To address the current unmet
need for an appraisal of the quality of RWE in AIT, the European Academy
of Allergy and Clinical Immunology Methodology Committee recently
initiated a systematic review of observational studies of AIT, which
will use the RELEVANT tool and the Grading of Recommendations
Assessment, Development and Evaluation approach (GRADE) to rate the
quality of the evidence base as a whole. The next step will be to
develop a broadly applicable, pragmatic “real-world” database using
systematic data collection. Based on the current RWE base, and
perspectives and recommendations of authorities and scientific
societies, a hierarchy of RWE in AIT is proposed, which places pragmatic
trials and registry data at the positions of highest level of evidence.
There is a need to establish more AIT registries that collect data in a
cohesive way, using standardised protocols. This will provide an
essential source of real-world data that can be easily shared, promoting
evidence-based research and quality improvement in study design and
clinical decision-making.