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.
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
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
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
Industry Expert Forum
PIVOT Sponsors from Prior Years
PIVOT Strategic Collaborators
Evidera
As a key COPD Foundation collaborator, Evidera, as part of the PPD clinical research business of Thermo Fisher Scientific, provides expertise and leadership in patient-centric instrument development that will be harnessed to help build PIVOT's Core Outcome Sets and identify, develop, and validate relevant measurement instruments. As part of the collaboration, the Foundation welcomes Evidera's Vice President of Scientific Affairs and Patient-Centered Research, Nancy Leidy, to PIVOT's Scientific Committee as the Senior Advisor for Measurement Instrument Methodology.
Want to learn more and/or interested in being involved in PIVOT?