Before approving a new medical device, regulators evaluate its safety and effectiveness. This includes considering the successful achievement of predetermined clinical trial results. To date, patients have had limited input on how clinical trial success is defined.
The Medical Device Innovation Consortium (MDIC) https://mdic.org program has released a new framework in order to provide U.S. medical device companies a systematic approach for patient focused clinical trial design to better meet patient needs and priorities.
The Science of Patient Input (SPI) with representatives from FDA, patient advocacy groups, and the medical device industry have developed the approach so that the studies used to evaluate medical devices can better align with patients’ interests.
Potential Benefits for Incorporating SPI into Clinical Trial Design are to:
- Provide Clinical Trial outcome data that matters to patients
- Increase the development of devices that patients find useful
- Develop increased patient trust in medical devices
- Determine clear patient preferences regarding risk/benefit of medical devices
- Provide for faster study/research participant recruitment, enrollment, and study completion
- Obtain greater study/research participation resulting in decreased loss to follow-up
- Streamline data collection which results in better quality data
- Need fewer protocol revisions.
The approach is detailed in the new SPI framework “Using Patient Preference Information in the Design of Clinical Trials. According to MDIC, SPI Program Director Kert Gunasekaran, “Our SPI program embraces the opportunity for industry to incorporate patient input more systematically into the process of developing products, enhances our pathways to deliver unmet needs for patients, and ultimately speeds access to new therapies.