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Review
. 2022 Nov;50(11):3000605221133689.
doi: 10.1177/03000605221133689.

Comparison between clinical trials and real-world evidence studies on biologics for severe asthma

Francesco Menzella  1 , Andrea Ballarin  1 , Maria Sartor  1 , Ariel Fabian Floriani  1 , Lorenzo Corsi  1 , Cristina Dartora  1 , Silvia Tonin  1 , Micaela Romagnoli  2
Affiliations
Review

Comparison between clinical trials and real-world evidence studies on biologics for severe asthma

Francesco Menzella et al. J Int Med Res. 2022 Nov.

Abstract

In recent years, the more widespread availability of biological drugs with specific mechanisms of action has led to significant breakthroughs in the management of severe asthma. Over time, numerous randomised clinical trials have been conducted to evaluate the efficacy and safety of these biologics and define the eligibility criteria of patients suitable for various therapeutic options. These studies were conducted under controlled conditions not always applicable to real life. For this and other reasons, real-world evidence and pragmatic studies are required to provide useful information on the effectiveness of biological drugs and their safety, even in the long term. Because differences in outcomes have sometimes emerged between clinical trials and real-life studies, it is important to clarify the causes of these discrepancies and define the significance of the results of studies conducted in the course of daily clinical practice. Thus, a scientific debate is ongoing, and no consensus has been reached. The purpose of this narrative review is to analyse the differences between randomised trials and real-world evidence studies, focusing on their roles in guiding clinicians among different therapeutic options and understanding the reasons for the large discrepancies often found in the results obtained.

Keywords: Severe asthma; biologics; clinical trial; efficacy; real-life; real-world evidence; safety.

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Conflict of interest statement

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: FM received research funding as the principal investigator from AstraZeneca, Chiesi Farmaceutici, Novartis, and Sanofi and fees as speaker/lecturer from AstraZeneca, Chiesi Farmaceutici, GlaxoSmithKline, Novartis, and Sanofi. The other authors declare that they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Pros and cons of clinical trials and real-life studies.
See this image and copyright information in PMC

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