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 ).

*Click for larger image

Patient-Centric Conceptual Framework

PIVOT Steering Committees

The PIVOT Steering Committees (SC) comprise clinical and scientific experts, and patient partners with lived experience expertise, who help to steer the project by providing support, guidance, and oversight of progress. SC members include:

COPD Steering Committee (SC)

  • Alan Hamilton, PhD (COPDF, Canada)
    PIVOT SC Chair
    COPD Foundation, Senior Director of Research
  • Àlvar Agusti, MD, PhD, FRCPE, Honorary ERS member, FERS (Spain, European Union)
    PIVOT COPD SC Clinical and Scientific Expert
    Professor of Medicine, University of Barcelona
    Senior Consultant. Respiratory Institute, Hospital Clinic, University of Barcelona
  • Brad Drummond, MD (North Carolina, United States)
    PIVOT COPD SC Clinical and Scientific Expert
    Associate Professor, University of North Carolina at Chapel Hill
  • Jerry A. Krishnan, MD, PhD (Illinois, United States)
    PIVOT COPD SC Clinical and Scientific Expert
    Professor of Medicine and Public Health
    Associate & Vice Chancellor for Population Health Sciences
    University of Illinois Chicago
  • Elina Price (Ireland, European Union)
    PIVOT COPD SC Patient Research Partner
    COPD Foundation Captain
  • Jean Rommes, PhD (Iowa, United States)
    PIVOT COPD SC Patient Research Partner
    COPD Foundation Community Engagement Committee & COPD360Net SC
  • Ruth Tal-Singer, PhD (COPDF, United States)
    PIVOT SC Clinical and Scientific Expert
    COPD Foundation, President & CEO

Bronchiectasis Steering Committee (SC )

  • Alan Hamilton, PhD (COPDF, Canada)
    PIVOT SC Chair
    COPD Foundation, Senior Director of Research
  • James Chalmers, MBChB, PhD (Dundee, UK)
    EMBARC Chair and Asthma and Lung UK Chair of Respiratory Research
    Professor, University of Dundee
  • Mark Metersky, MD, FCCP (Connecticut, US)
    PIVOT Bronchiectasis SC Clinical and Scientific Expert
    Professor of Medicine
    Chief, Division of Pulmonary, Critical Care, and Sleep Medicine
    Director, Center for Bronchiectasis Care
    UConn Health
  • Pamela (PJ) McShane, MD, FCCP (Texas, US)
    PIVOT SC Bronchiectasis Clinical and Scientific Expert
    Associate Professor of Medicine
    UT Health - University of Texas Health Science Center Tyler
  • Mary Kitlowski (Maryland, US)
    PIVOT Bronchiectasis SC Patient Research Partner
    Founder and President, Running On Air
  • OPEN - GLOBAL
    PIVOT NTM Lung Disease SC Patient Research Partner #2
  • Ruth Tal-Singer, PhD (COPDF, United States)
    PIVOT SC Clinical and Scientific Expert
    COPD Foundation, President & CEO

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

Contact: pivot@copdfoundation.org