Module 15 · Part 5 · Partnerships

Working with Industry Sponsors

Build productive partnerships with pharmaceutical and biotech companies while protecting participant interests, data integrity, and your organization's independence.

Patient Registries 101 · Dr. Danielle Boyce · EpilepsyLive

The opportunity and the risk

Patient registry data is extremely valuable to the pharmaceutical industry.
Serve as a comparator arm for single arm clinical trials
Provide pre-screened participants for trial recruitment
Support regulatory submissions as real world evidence
Inform trial endpoint selection and outcome measure development
Enable postmarket surveillance studies

The opportunity and the risk (cont.)

This creates leverage for your organization.

Data licensing

A company pays for access to your registry data, either aggregate analyses, deidentified individual records, or (with additional consent) identified data.
Key protections
You retain data ownership; the license is time-limited and purpose-limited
Use restrictions must be explicit: no reidentification, no secondary commercial use, no data sale
Define the expiration and data destruction obligations
Reserve the right to publish independent analyses

Natural history partnership

A company funds registry operations in exchange for being able to use your natural history data to support their regulatory submission.
Key protections
This is a research partnership, not a sponsorship, maintain scientific independence
Your SAB (not the company) controls data element selection and analysis plans
You retain publication rights
Any FDA meetings where registry data is presented should include advocacy organization representation

Recruitment partnership

A company compensates your registry for identifying and referring eligible participants to their clinical trial.
Key protections
Referral must be genuine and patient-centered, never pressure participants to enroll in trials
Compensation should be transparent and fair market value
Participants must understand the distinction between registry participation and trial enrollment
Your organization should never receive per-enrollment payment in ways that create incentive to over-refer

Negotiating the data use agreement

The DUA is the most important document in an industry partnership.

Protecting participant trust

Your community's trust is your most valuable asset, worth more long term than any individual industry partnership.
Being transparent with participants about industry partnerships in your consent document
Publishing an annual transparency report disclosing funding sources
Never allowing industry partners to contact participants directly
Maintaining independent scientific governance
Being willing to decline partnerships that conflict with participant interests

Key resources

PhRMA Principles on Conduct of Clinical Trials
NORD Participant Advocacy Summit Resources
EFPIA Participant Engagement Framework
FDA Guidance: Natural History Data for Regulatory Submissions
← Module 14 | Module 16: Working with Academia →