Editor’s Pick: Identifying Shared Features and Addressing Common Challenges in Clinical Trials for Chronic Inflammatory Diseases: An Overview

Abstract

Chronic inflammatory diseases (CID) share many common features, such as debilitating illness, increased mortality, impaired quality of life and productivity, and high economic burden. The approach to treating CID has shifted over the last 20 years from symptom to mechanism of action-targeted therapy following the development of primarily biologic drugs, in which the same therapy can potentially treat multiple diseases. Developing these drugs requires novel strategies and a multidisciplinary approach for implementation. This article provides an overview of shared features for CID clinical trials and addressing common challenges in their planning and execution. Since CID studies often test the same drug for treating different pathologies, knowledge of the drug from previously investigated therapeutic indications can be leveraged when planning clinical trials. Given the variety of CID signs and symptoms, eligibility criteria need to clearly define the target patient population by minimising ambiguity and risk of misunderstanding. Other common challenges include an elevated response in the placebo arm, the subjectivity of investigator assessments, and the use of appropriate patient-reported outcomes. Several measures can help minimise the impact of the aforementioned issues on study outcome, including centralised eligibility review and endpoint adjudication, tight control of background therapy and concomitant medications, and intensive training of assessors. The above common features support an approach to CID as a largely interconnected therapeutic area in which a multidisciplinary approach, application of common strategies, and lessons learnt across different indications represent crucial factors for effectively planning and executing clinical trials.