Driving multi-stakeholder acceptance of patient generated health data (PGHD) for use in clinical trials

Interested? Who to contact:

@Paul Denny-Gouldson (Unlicensed)

@Ashley George (Unlicensed)

The problem:

Use of Patient-Generated Clinical Data is not widespread at this time and it could represent a new way to help define endpoints and outcomes in trials if properly managed and quality assured.

Proposal:

Draft multistakeholder developed draft guidance for the use of PGHD in industry-sponsored studies of new drugs and new applications of existing drugs.

To better understand the collection and use of patient-generated health data (PGHD) and digital measures in the evaluation of drug safety and efficacy:

1. Better understand how studies utilizing PGHD and digital measures can be designed, beginning with a patient-centered approach

2. Develop quality control requirements for data generated from wearables, apps, and sensors in order for them to be trusted in the regulatory setting. This will include, but not be limited to, COU considerations, verification, and validation, technical requirements, etc.

3. Evaluate how PGHD, given its continuous nature, can yield more accurate and sensitive measures than the current standard of care based on sporadic measurements

4. Determine whether and when digital data collection methods that are not blinded to the patients may impact outcomes

5. Collaborate on how this novel data can be analyzed in a manner that meets regulatory standards, including packaging and submitting the data to the FDA

6. Ascertain how CDER can best be prepared to receive and review these novel data and analyses

7. Ensure PGHD study designs, standards and processes for medical devices are harmonized with those of other divisions across the Agency.