Patient-Inspired Validation of Outcome Tools (PIVOT)

Patient-Inspired Validation of Outcome Tools (PIVOT)

PIVOT is a patient-centric framework for the coordination of activities for the development, validation, and qualification of biomarkers and clinical outcome assessments for use in the evaluation of treatment benefit for pharmacological and non-pharmacological approaches in COPD, bronchiectasis, and other chronic lung diseases.

PIVOT: Patient Inspired Validation of Outcome Tools

Watch the video to learn more about PIVOT.

Integrating the Patient Perspective

In recent years there has been an increased emphasis on the value (and necessity) of integrating the patient perspective in the development, validation, and qualification of measurement instruments intended for the evaluation of treatment efficacy and treatment benefit of medical products (drugs and biologics, medical devices, and digital health tools). The approach has been formally recognized for several years in initiatives such as OMERACT1. More recently, the FDA has formalized this concept within a regulatory framework by publishing several Patient-Focused Drug Development (PFDD) guidance documents2.

In October 2021, the COPD Foundation organized a chronic lung disease patient listening session with the FDA, SOS for Breath. The session highlighted the common elements of disease burden, such as breathlessness and activity limitation, across chronic lung diseases, such as COPD, Bronchiectasis, Pulmonary Fibrosis, A1AT deficiency, and Asthma. The success of the event highlighted an opportunity for the COPD Foundation to assume a leadership role in integrating the voice of the patient in the identification of a "Core Outcome Set that Matters to Patients," which could then form the basis for an organizational framework for further development, validation and ultimately qualification of biomarkers and clinical outcome assessments across chronic lung diseases.

With the formal close-out of the CBQC in 2021, the scientific leadership of the COPD Foundation embarked on a strategic pivot and established the PIVOT for Patients initiative (Patient-Inspired Validation of Outcome Tools ).

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Patient-Centric Conceptual Framework

Want to learn more and/or interested in being involved in PIVOT?