Meaningful Patient Engagement is More than an App or Big Data

Washington, DC (September 22, 2015) – The concept of patient engagement is gaining momentum as a practical and ethical way to improve health care outcomes. Central to this movement is the focus on how therapies can be generated, developed, studied, and evaluated to ensure they better meet patient needs. But a framework for doing so has not emerged.

To help navigate a path forward driven by the patient perspective and to lay out action steps, the National Health Council and Genetic Alliance convened a meeting of the key thought leaders on the issue and released their findings in a white paper around a vision for advancing patient engagement in the research-to-care continuum.

The report, Dialogue/Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs, addresses in depth three main barriers to meaningful patient engagement:

  • The uncertainty regarding how patient-provided data will impact product approval by the Food and Drug Administration (FDA);
  • The cultural divide over the use of patient information, including the perception that gathering patient information does not follow science-based approaches; and
  • The large knowledge and information gap about patient engagement methods, best practices, and successes.

The report also identifies action steps that target specific issues. Various stakeholders in the health system bring different perspectives, needs, experiences, and approaches to the issue. All stakeholders – the patient community, researchers, regulatory agencies, and industry – have important roles to play at different stages in moving patient engagement forward. For example, the white paper addresses

  • The need to create regulatory guardrails and enhance FDA division alignment on the use of tools for evaluating patient information;
  • The importance of promoting a culture shift to generate buy-in for patient engagement, creating accountability for collecting and integrating patient perspectives, and educating researchers; and
  • The tactics for facilitating opening communication, including creating a feedback system to inform patients about how their contributions impact decisions and making patient engagement successes and best practices both comprehensible and publicly available.

The white paper, prepared by Avalere Health, is the result of a forum held March 2, 2015, at the Food and Drug Administration (FDA) White Oak Campus in Maryland and that was attended by representatives from the patient advocacy community, federal government, academia and researchers, and industry.

To download the white paper, visit

About the National Health Council

Founded in 1920, the National Health Council (NHC) is the only organization that brings together all segments of the health community to provide a united and effective voice for the more than 133 million people living with chronic diseases and disabilities and their family caregivers. Made up of more than 100 national health-related organizations and businesses, its core membership includes the nation’s leading patient advocacy organizations, which control its governance. Other members include professional and membership associations, nonprofit organizations with an interest in health, and major health insurance, pharmaceutical, medical device, and biotechnology companies.

About Genetic Alliance

Genetic Alliance engages individuals, families, and communities to transform health. Founded in 1986, it is one of the world's largest nonprofit health advocacy organization networks. Genetic Alliance's network includes more than 1,200 disease-specific advocacy organizations, as well as thousands of universities, private companies, government agencies, and public policy organizations. Genetic Alliance values openness and transparency as a mechanism for transformation and challenges the status quo in health systems and research. For more information about Genetic Alliance, visit


Nancy Hughes,, 202-973-0550
Tanya Murza,, 202-966-5557