The central theme of this special issue of the Journal of Thoracic Disease (JTD) is real-world effectiveness research (observational studies and pragmatic trials) in the context of respiratory disease.There has been growing recognition in recent years of the need for real-world methodologies and the value of real-life evidence to supplement and complement the existing safety and efficacy evidence reported in registration randomized controlled trials (RCTs). As the REG 2016 summit report in this issue outlines, the event debated and discussed important areas of current and potential influence of real-life research, in clinical practice, market access, guideline development and regulatory issues as well as showcased the results from some of the on-going real-world studies being delivered by REG’s specialty working groups. The summit also featured six thematic abstract sessions across the 2 days: Safety and Risk; Diagnostic Practice; Pragmatic Approaches; Validation and Tool Development; Healthcare Resource Utilisation; Late Breaking Research. The high-quality research presented in these sessions is also included in this issue.
