The COPD Foundation introduced PIVOT Framework (Patient Inspired Validation of Outcome Tools), a patient-centric framework that will support the coordination of activities for developing, validating, and qualifying biomarkers and clinical outcome assessments that evaluate the benefit of treatment approaches in COPD, bronchiectasis, and NTM lung disease.
“The program is an intentional ‘pivot’ to the future for patients, the Foundation, and academic and industry research partners. PIVOT will establish a conceptual framework that shifts the approach to how lung disease treatments are developed and evaluated,” explained Ruth Tal-Singer, PhD, President & CEO of the COPD Foundation.
“While significant strides have been made to improve care for those with COPD, the last regulatory approval of a medicine with a new mechanism of action in COPD was in 2011,” she said. “In recent years, we’ve learned a lot through the regulatory process, patient input, and the successes and learnings from the COPD Biomarker Qualification Consortium (CBQC), which has significantly informed our shift in strategy.”
Alan Hamilton, PhD, Senior Director of Research and PIVOT program lead, with extensive clinical, scientific, and operational experience in this field of study, explained that PIVOT Framework is the next evolutionary step toward defining and acting on treatment benefits for patients with chronic lung diseases.
“Working together with patients to fully understand their lived experience, we will be able to establish the relationship between a measurement instrument and the meaningful aspect of how a patient feels or functions in daily life,” he said. “Through PIVOT, patients will be involved at the center, and both academia and industry partners will benefit from shared knowledge. The work will inform efforts by our collaborators in organizations advocating for chronic lung disease treatments,” Hamilton added.
“The notion of a meaningful aspect of health in a person’s life is what a patient cares about,” said Tal-Singer. “The Foundation is ideally positioned to be a driving force in this framework as an advocate for patients, coupled with critical input from clinicians, academic researchers, and industry collaborators.”
PIVOT Framework will be used as a central organizing framework to evaluate the benefits of pharmacological and non-pharmacological treatment approaches in COPD, bronchiectasis, and NTM lung disease. The Foundation welcomes the participation of academic and industry research partners in this evolutionary process.