New commentary highlights the need for patient-inspired frameworks to guide COPD therapy development, aiming to improve outcomes and create more effective, patient-centered treatments.
RT’s Three Key Takeaways:
- Patient-Inspired Frameworks: New commentary emphasizes the importance of incorporating patient perspectives into COPD drug development through frameworks like the COPD Foundation’s PIVOT initiative, which validates outcome measures inspired by patient experiences.
- Benefits of Patient-Centric Approaches: The commentary notes that integrating patient insights can lead to more efficient drug development, improved clinical trial designs, earlier access to treatments, and the use of patient-centered language in educational and prescribing materials.
- Alignment with FDA Guidance: A patient-centric approach aligns with the FDA’s Patient-Focused Drug Development guidance, aiming to create therapies that better address the needs and priorities of individuals living with COPD.
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 Role of the PIVOT Initiative
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 US Food and Drug Administration Patient-Focused Drug Development guidance series and establishes a patient-centric framework for identifying, testing, and communicating treatment benefit,” says Alan Hamilton, PhD, senior director of research at the COPD Foundation and lead author of the article, in a release. “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.”
Advancing Patient-Centric Drug Development
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,” Hamilton says in a release. “This will give us the opportunity to maximize the treatment benefit of new therapies for patients.”
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