by COPD Foundation

The mechanistic model is a logical link between patient-inspired health concepts, a drug's mechanism of action, and subset of measures selected to test and communicate product-specific treatment benefit. Adaptation of the generic conceptual framework described in PFDD Draft Guidance 3.2 .Abbreviations: COA = clinical outcome assessment; ObsRO = observer-reported outcome; PRO = patient-reported outcome. Credit: Annals of the American Thoracic Society (2024). DOI: 10.1513/AnnalsATS.202408-864IP

The perspectives and priorities of people living with chronic obstructive pulmonary disease (COPD) should be integrated into the development process of new therapies for COPD, according to a new commentary. The article is published in the Annals of the American Thoracic Society.

COPD comprises several conditions, including chronic bronchitis and emphysema, and can be caused by genetics and irritants like smoke or pollution. The disease affects more than 15 million Americans and is the fourth leading cause of death worldwide, yet awareness of the disease's symptoms, methods to reduce risk, and disease management remains poor.

The commentary discusses the COPD Foundation's PIVOT (Patient-Inspired Validation of Outcome Tools) initiative, a patient-centric framework to validate outcome measures for use in clinical trials in COPD. A foundational component of PIVOT is the creation of a unified set of patient-inspired health concepts in COPD.

"The development of a unified set of patient-inspired health concepts in COPD is aligned with the U.S. Food and Drug Administration Patient-Focused Drug Development guidance series and establishes a patient-centric framework for identifying, testing and communicating treatment benefit," said Alan Hamilton, Ph.D., Senior Director of Research at the COPD Foundation and lead author of the article.

"We have worked closely with people with COPD who want more involvement in health care decision making. They bring valuable first-hand insights based on their lived experience to the development of drugs and other interventions for the disease."

Dr. Hamilton and co-authors describe several advantages of a set of patient-inspired health concepts, including increased efficiencies in medical product development, earlier access to new treatments, improved research study design and more patient-centric language in educational materials, prescribing information and other patient-focused information.

"By taking the necessary steps to integrate patient perspectives through the development of patient relevant health concepts, we can inspire innovative and expedited therapeutic solutions for COPD," Dr. Hamilton said. "This will give us the opportunity to maximize the treatment benefit of new therapies for patients."

More information: Alan Hamilton et al, A Unified Set of Patient-Inspired Health Concepts for COPD: A North Star for Understanding Treatment Benefit, Annals of the American Thoracic Society (2024). DOI: 10.1513/AnnalsATS.202408-864IP

Provided by COPD Foundation