Empower Your Patient Community Voice

Starting a Patient Group

Although there are ways for patients to engage in different aspects of the therapy development process without belonging to a patient group, that is not the focus of NCATS Toolkit. In general the voice of a patient group offers clinicians, researchers, and industry a more diverse perspective and has a greater impact. If there is a patient group that already exists, working within the existing group can keep your disease community united, avoid duplication of efforts, and reduce competition for resources. If you are certain there is not an existing group that includes your disease, you may consider starting one.

Social media groups: Today, many nonprofit patient groups for rare and genetic diseases begin as social media groups. Social media groups can quickly connect people/families who are affected by the same rare disease.
- If there is already a social media group, reach out to the administrators and moderators (on Facebook these can usually be found on the About page for the group) to see whether there is interest in forming a nonprofit with a mission to advance the development of medical therapies.
- If there is not a social media group, you may wish to start one. Using the disease name or associated gene in the title of the group can help others find it.
- Facebook has information about starting a group located at:
  - Group Basics
  - What are the privacy settings for groups?
Forming a nonprofit: Once you have connected with other patients/families, you may want to see if anyone is interested in forming a nonprofit group. The tasks involved in forming a new group are best accomplished by having several people willing and able to dedicate the necessary time and effort.
- It may be a good idea to consider what roles you and the other members would like the group to fill.
  - For example, a group’s mission may include:
    - Supporting research and medical therapy development.
    - Allowing families to connect and share resources.
    - Building a registry.
    - Establishing centers of excellence.
  - For more information about the many roles filled by support and advocacy groups, please see the GARD guide, Support for Patients and Families
- The following resources can help you learn more about forming a nonprofit patient group:
  - Global Genes is a leading rare disease patient advocacy group whose mission is to “eliminate the challenges of rare disease.” Two of their toolkits are devoted to starting non-profit advocacy organizations:
    - So You Think You Want To Start A Nonprofit
    - Starting A Nonprofit: The First Steps
  - National Organization for Rare Disorders (NORD) is another leading patient advocacy group dedicated to individuals with rare diseases and the organizations that serve them. They offer several resources for those considering starting a patient group.
    - Steps to Nonprofit Formation is a review of the steps necessary to achieve 501(c)(3) nonprofit status. The guide also addresses frequently asked questions, such as the cost and time associated with establishing a disease foundation.
    - Nonprofit Resources is a list of resources to help provide information about managing, establishing, or finding nonprofit foundations. The resources include newsletters, nationally-based centers, and lists of charities.
  - The Foundation Group also has helpful information about starting a nonprofit, including an explanation about gaining 501(c)3 status including the benefits and limitations imposed by this status. The Foundation Group is a company however, not a nonprofit.
    - What is a 501(c)3?

Resources

Making a Difference

From Molecules to Medicine: How Patients Can Share Their Voices Throughout the Drug Development Process Global Genes (link)

Data DIY – Your Involvement in Driving Understanding, Discovery, and Treatments for Rare Disease Global Genes (link)

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making U. S. Food and Drug Administration (FDA) (link)

Nonprofits: Innovators in Preclinical Drug Development FasterCures (link)

Faster Cures Webinars FasterCures (link)

From Anecdotal to Actionable: The Case for Patient Perspective Data FasterCures (link)

FasterCures Patients Count Program FasterCures (link)

On the Path to a Science of Patient Input FasterCures (link)

Innovator Spotlight FasterCures (link)

Discovery Documentary: First in Human NIH Clinical Center (link)

Assessing Meaningful Engagement in Drug Development: A Definition, Framework, and Rubric University of Maryland Center of Excellence in Regulatory Science and Innovation (link)

Principles of Community Engagement: Second Edition Agency for Toxic Substances and Disease Registry (link)

Finding a Group

GARD Organization Database Genetic and Rare Diseases Information Center (GARD) (link)

Starting a Patient Group

GARD Guide: Support for Patients and Families Genetic and Rare Diseases Information Center (GARD) (link)

So You Think You Want To Start A Nonprofit Global Genes (link)

Starting A Nonprofit: The First Steps Global Genes (link)

Steps to Nonprofit Formation National Organization for Rare Disorders (NORD) (link)

Nonprofit Resources National Organization for Rare Disorders (NORD) (link)

What is a 501(c)(3)? Foundation Group (link)