Background: Clinical trials should be designed to represent the population for which the medicinal product is intended. Indeed, US and EU regulatory agencies call for stronger consideration of “neglected pop-ulations” when evaluating clinical trial results for new pharmaceutical products. However, methods to identify and assess representation or lack hereof in clinical trials are scarce.
Objectives: This pilot study aims at identifying possible “neglected populations” of asthma medication use by assessing the representativeness of phase III clinical trial asthma populations.
Methods: Utilizing real-world data from Danish national registries, this study develops and test a method to assess the representativeness of phase III clinical trials of asthma medication by comparing the clinical trial population with the population of “real-world” asthma medication users. From national registers, we identify all Danes aged ≥2 years with a diagnosis of asthma or who have redeemed at least one prescription for an asthma medication in period from 1st January 2015 to 31st December 2020. From the European Union Drug Regulation Authorities Clinical Trials Database (EudraCT), we identify phase III clinical trial populations for the evaluation of asthma medications completed by 1st January 2015. We compare characteristics of real-world people with asthma and users of asthma medication with characteristics of the clinical trial asthma populations, including demographics (age and sex) and health status (co-morbidities and co-medication). Additionally, we will focus on the representativeness of pregnant women in clinical trials, as asthma is a chronic condition and use during pregnancy is expected.
Results: Results are pending and will be presented at the conference.
Conclusions: Conclusions are pending and will be presented at the conference.
