Determine Patients’ Needs

Contact Registry

Contact registries typically are focused on including people with a specific disease or condition who may be interested in becoming involved in future clinical trials.

Type of information stored may include:
- Contact information of the patient.
- Demographic information, such as age or sex.
- Basic health information that may be important to determine clinical trial eligibility.
Purpose:
- Patients in the registry can be notified when a clinical trial or research opportunity becomes available.
- Patients can learn about opportunities to provide feedback to the FDA and advisory committees.
- Medical researchers and Industry Partners can seek out patients to be involved in surveys, focus groups, and clinical trials.
Advantages:
- Allows researchers in academia and industry to identify people willing to be involved in clinical trials.
- In most cases, the system sends the information about the trial directly to the patient instead of providing the principal investigator (or PI) with the patient’s contact information.
- Being part of a contact registry does not obligate a person to join a clinical trial.
- Minimal effort to set up and maintain.
- Your group’s member contact list can provide a good base to start a contact registry.
- If disease pathology and patient population is well characterized, a contact registry may be sufficient.
Challenges:
- Collects only minimal, if any, information about the disease from patient or clinical perspective and therefore will not provide specific information about the disease or patient population.
- In comparison to a group’s member contact list, a contact registry database:
  - Should separate contact information and other personal identifying information from health information.
  - Requires clear informed consent so that those providing information know what is being done with information, how it will be stored, and who will have access.

Resources

Patient Registries

From Molecules to Medicine: How Patients Can Their Voices Throughout The Drug Development Process Section 5 and 6 Global Genes (link)

Rare Disease Registries: Advancing Disease Understanding, Treatments, and Cures Global Genes (link)

List of Registries National Institutes of Health Clinical Center (link)

Natural History Study

FAQ Orphan Products Natural History Grants Program U. S. Food and Drug Administration (FDA) (link)

Find Funding Opportunities through Office of Orphan Products and Development Development (OOPD) U. S. Food and Drug Administration (FDA) (link)

OOPD Grant Application Overview U. S. Food and Drug Administration (FDA) (link)

Natural History Clinical Trials Global Genes (link)

Building a Registry

Rare Diseases Registry Program (RaDaR) National Center for Advancing Translational Sciences (NCATS) (link)

PFDD Initiative

The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative U. S. Food and Drug Administration (FDA) (link)

FDA-led Patient-Focused Drug Development (PFDD) Public Meetings U. S. Food and Drug Administration (FDA) (link)

Implementation Manual: How to Operationalize the National Health Council's Patient Information Tool National Health Council (link)

Patient-Focused Drug Development Meetings: Smart Practices from Community Leaders FasterCures (link)

External Resources or Information Related to Patients’ Experience U. S. Food and Drug Administration (FDA) (link)

Planning an Externally-Led PFDD

Guidelines for Developing a Letter of Intent (LOI) for Externally-Led Patient Focused Drug Development Meetings U. S. Food and Drug Administration (FDA) (link)

FDA-led Patient-Focused Drug Development (PFDD) Public Meetings U. S. Food and Drug Administration (FDA) (link)

FDA’s CDER Patient-Focused Drug Development Program Staff U. S. Food and Drug Administration (FDA) (link)

Externally-led Patient-Focused Drug Development Meetings U. S. Food and Drug Administration (FDA) (link)

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders U. S. Food and Drug Administration (FDA) (link)