Capturing and Including the Patient Voice
There is little consensus-based guidance on how to conduct patient engagement or assess whether an approach to patient engagement will yield meaningful results for all parties involved. The NHC seeks to identify and implement best practices for integrating the patient voice into the conduct of research and health care decision making.
The NHC aspires to ensure patient centricity in our health care ecosystem through the implementation of Patient-Centered Core Impact Sets (PC-CIS). Learn more here.
A Guide to Incorporating the Patient Voice into the Health Ecosystem
Read the Rubric here.
The NHC wants to ensure that all stakeholders confidently enter into ongoing, compliant, and sustainable engagement efforts that effectively drive health care innovation based on patient and caregiver insights, which must be collected in a trusted and high-quality manner. This project aims to support sustainable agreements between stakeholders and the patient and caregiver community as part of medical product development. View the toolbox.
Patient-focused drug development (PFDD) recognizes the value of engaging patients throughout drug development. Life-science companies, known commonly as sponsors, aim to engage patients so that they can develop medicines that align with patient needs, resulting in better patient outcomes. However, many sponsors struggle with engaging patients in all but the most basic ways because of regulatory and legal uncertainty and lack of clear guard rails on non-promotional interactions with patients. To discuss issues associated with sponsor-patient interactions in drug development and identify good practices for those interactions, the National Health Council (NHC), Genetic Alliance (GA), and the Food and Drug Law Institute (FDLI) brought together 90 drug-development stakeholders from patient advocacy groups, life-science companies, professional associations, industry trade associations, academic institutions, nonprofit organizations and institutes, and government agencies for a one-day public meeting on June 15, 2017. Learn more here.
This glossary will help patients, patient advocates, and other health care stakeholders understand what common terms mean and ensure that everyone collaborating to make health care more patient-centric is speaking the same language.
Patient-focused medical product development is a mechanism by which stakeholders, including but not limited to medical product developers, academics, and regulators, form a partnership with patients to enhance medical product development, throughout the research, regulatory, and reimbursement processes.
Read the case examples here.
The National Health Council (NHC) is focused on ensuring the patient’s journey is collected in standardized ways to inform patient-centric efforts in research, product development, and care delivery. We want to leverage the tools available and communicate shared learnings. To that end, we have developed a Patient Experience Mapping Toolbox.
As stakeholders across the health care ecosystem embrace patient centeredness and integrate the patient voice into their processes, decisions, and organizations, meaningful patient engagement has become increasingly important during drug development, regulatory product review, and value assessment. In practical terms, this means that patients, including caregivers, advocates, and advocacy organizations, are active, respected, and full partners in the endeavor, and their views are incorporated into all processes. Read more here.
The NHC partnered with the Pharmacy Quality Alliance (PQA) and the National Quality Forum (NQF) to create the Patient Engagement in Quality Measurement Rubric. This guide was created to help include meaningful patient engagement to the quality measure lifecycle.
Patient Engagement Compensation and Contracting Toolbox
The NHC and our partners have developed tools, including a first-of-its-kind Fair-Market Value (FMV) Calculator, to assist all stakeholders to confidently enter into ongoing, compliant, and sustainable engagement efforts that effectively drive health care innovation based on patient and caregiver insights, which must be collected in a trusted and high-quality manner.
Patient-Focused Medical Product Development Webinar Series
The NHC’s Patient-Focused Medical Product Development series builds upon our Clinical Outcome Assessment (COA) series, which we hosted between Nov. 2018-Dec. 2019. The series will continue to introduce COA-related topics, but also will cover a broader range of subjects, including patient preference research, patient engagement in clinical trial design, as well as medical device development.
HEALTH CARE QUALITY
This training program focuses on why quality is important in the current health care environment and how patients and patient organizations can become strong advocates for quality.
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Webinars
Optimizing Digital Health Trials by Engaging Patients and Sites
01/12/2021 2:00 pm, Virtual, Zoom Read MoreHealth Literacy Throughout Drug Development: Why it Matters to Pharma and to Patients
09/24/2020 3:00 pm, Zoom Read MorePatient-Focused Medical Product Development: Real-World Case Examples
08/13/2020 2:00 pm, Zoom Read MoreWhat is the Role of Patient-Reported Data in Outcomes-Based Contracts?
03/23/2020 2:00 pm, Webex Read MoreLetters & comments
NHC Comments on FDA-2020-D-2316 for Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry
11/29/2021 Read More
NHC Comments on PDUFA Reauthorization Performance Goals and Procedures FY 2023-2027
10/29/2021 Read MoreNational Library of Medicine’s (NLM) Request for Information on ClinicalTrials.gov Modernization
03/12/2020 Read MorePatient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making; Public Workshop
02/03/2020 Read MoreSupport
