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.

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.

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.

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 will develop 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. 

NEW: Sponsor-Patient Engagement 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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