Integrating Rare Disease Patients into Pre-Clinical Therapy Development; Finding our Way with Patient Input
BioPontis Alliance for Rare Diseases
This white paper reports on a 2016 workshop held to define methods and practices to enable integration of patients into...
Identifying and Delivering the Essential Elements of Patient-Centered Cancer Care
Livestrong Foundation
Seven building blocks and 23 elements of patient-centered cancer care are presented as an outcome of research from 150 sources...
Principles for Making Health Care Measurement Patient-Centered
American Institutes for Research
Five principles for patient-centered measurement were developed with input from a multidisciplinary group of stakeholders.
Harnessing Evidence and Experience to Change Culture: A Guiding Framework for Patient and Family Engaged Care
National Academy of Medicine
The National Academy of Medicine's Leadership Consortium convened a Scientific Advisory Panel to create this discussion paper on care delivered...
Emerging Guidelines for Patient Engagement in Research
International Society For Pharmacoeconomics and Outcomes Research (ISPOR)
Researchers describe strengths, challenges, and impact of partnering with patients to conceptualize, design, and conduct outcomes research, drawing on three...
The PCORI Engagement Rubric: Promising Practices for Partnering in Research
PCORI
The Rubric provides a framework for operationalizing engagement to incorporate patients and other stakeholders in all phases of research.
Integrating the Patient Perspective into the Development of Value Frameworks
FasterCures
This report resulted from Avalere and FasterCures’ workshop in 2015 that discussed the growing trend of creating value frameworks and...
Value and coverage Healthcare delivery Patient organizations
Patient Engagement Rubric & Evaluation Framework
PCORI
The Evaluation Framework attempts to capture questions about PCORI's goals and the methods used to achieve those goals, as well...
Compensation Framework for Engaged Research Partners
PCORI
This framework provides financial compensation guidelines for research proposals submitted to PCORI, as well as guidance for general planning of...
Patient Engagement Rubric
PCORI
This document summarizes PCORI's model for patient-centered outcomes research, including funding requirements, methods for involving diverse groups of stakeholders in...
Assessing Meaningful Patient Engagement in Drug Development: A Definition, Framework, and Rubric
University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI)
The document proposes a definition, conceptual framework and means of assessing the extent of patient-focused drug development, based on a...
Guiding Practices for Patient-Centered Value Assessments
National Pharmaceutical Council
A set of guiding practices for patient-centered value assessments of medical products composed of 28 elements in six key elements:...
Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of Medical Technology
Medical Device Innovation Consortium (MDIC)
This extensive report aims to improve the understanding of how the patient’s perspective can be incorporated into the regulatory approval process.
Dialogue / Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs
National Health Council and Genetic Alliance
This paper summarizes recommendations generated during a 2015 workshop attended by stakeholders from across sectors, including government, patient organizations,...
Clinical trials Patient organizations Patient focused drug development Training
From Anecdote to Actionable: The Case for Patient Perspective Data
FasterCures
A model for advancing the collection and application of patient perspective data, including initial ideas for how such data might...
Patients as Critical Partners in Rare Disease Development
Everylife Foundation
This framework outlines opportunities to engage patients in the development and delivery of therapies for rare diseases. (September 2015)
Visual Model of Patient Engagement in Benefit-Risk Assessment through the Medical Product Life Cycle
DIA
This visual model was created by participants at a DIA conference depicts how patients across the full spectrum of biomedical...
Recommendations: Patient Engagement Across the Research & Development Continuum
Clinical Trials Transformation Initiative (CTTI)
A comprehensive set of recommendations to guide development of collaborative relationships between sponsors of biomedical research and development and patient organizations.
Paths to Patient and Public Involvement for Medical Research Charities
Association of Medical Research Charities
This report provides guidance to medical research charities interested in adding patient-centric methods to their organization's activities. (October 2009)
Patient Engagement Mapping
Patient Focused Medicines Development
The PFMD mapping tool is a user-populated platform that categorizes and maps existing initiatives and frameworks to provide a snapshot...
Clinical trials Patient organizations Patient focused drug development
Principles of Community Engagement - 2nd Edition
Department of Health and Human Services (HHS)
Developed as part of the work of the Clinical and Translational Science Awards (CTSA) Consortium's Community Engagement Key Function Committee,...
Lifecycle Approach to FDA's Structured Benefit-Risk Assessment
BIO
This white paper identifies considerations for biopharmaceutical companies using FDA's Structured Benefit-Risk Assessment Framework throughout a product's lifecycle, including steps...
Roadmap Guides Patient and Family Engagement in Healthcare
American Institutes for Research
The roadmap highlights opportunities to improve the healthcare system by creating partnerships with patients and families to advance these efforts...
Patient and Family Engagement: A Framework for Understanding the Elements and Developing Interventions and Policies
Health Affairs
Author Kristin Carman discuss how patient engagement can occur across the health care system, from the direct care setting to incorporating patient...