COPD Drug Development: New Biomarkers and Regulatory Guidance Reshape Clinical Trials
This review summarizes US and EU regulatory guidance for COPD drug development, highlighting the validation of new patient-reported outcome tools and a prognostic biomarker for patient selection in clinical trials. With nearly 25 novel drug targets now in development after a decade-long drought, the field is seeing renewed interest driven by better disease understanding. For labs supporting COPD clinical trials, the evolving regulatory framework around biomarker qualification and endpoint validation is directly relevant.
The original study
Review of Drug Development Guidance to Treat Chronic Obstructive Pulmonary Disease: US and EU Perspectives.
- Authors
- van Haarst A, McGarvey L, Paglialunga S
- Journal
- Clinical pharmacology and therapeutics
- Type
- Journal Article, Review
- PMID
- 31334840
Original abstract
Chronic obstructive pulmonary disease (COPD) remains a leading cause of death worldwide, yet only one new drug class has been approved in the last decade. However, resurgence in COPD treatment has been recently fueled by a greater understanding of the pathophysiology and natural history of the disease, as well as a growing prevalence and an aging population. Currently, there are nearly 25 novel drug targets in development. Furthermore, the indication has undergone some fundamental changes over the last couple of years, including an updated diagnosis paradigm, validation, and approval of patient-reported outcome questionnaires for clinical trials, and drug development tools, such as a prognostic biomarker for patient selection. In the context of clinical trials, this review aims to summarize recent changes to the diagnosis and evaluation of COPD and to provide an overview of US and European regulatory guidance.