What is the issue?
Before approving a new medical device, regulators must evaluate its safety and effectiveness. One of the most important questions they ask is whether the clinical benefit of a device outweighs its risk. Patients can provide valuable input into the potential risks and benefits of a medical device, as well as provide insight into the design and development of new technology. Patients and their families have a deep and personal understanding of what it is like to live with a disease, and they often have valuable insights on how a device could affect their quality of life. And in the end, patients are the ones who take the risks in order to achieve the benefits of medical therapies.
The U.S. Food and Drug Administration (FDA) has encouraged medical device companies to include patient perspectives across the medical device development lifecycle. But device manufacturers still need more specific guidelines on how to collect and use patient perspectives across the medical device development lifecycle.
What is the goal of this project?
MDIC and its partners are collaborating to improve our ability to include patient perspectives in the development, pre-market approval, and post-market evaluation of medical devices. The vision of the MDIC Science of Patient Input Steering Committee is to provide a venue for continued collaboration to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating the patient’s perspective and preferences in the design, clinical development and regulatory review of innovative medical technologies
This project expands on the MDIC Patient Centered Benefit-Risk (PCBR) project, which was launched in 2013 with the vision “to establish a credible framework for assessing patient preferences regarding the probable benefits and risks of a proposed medical device and for incorporating patient preference information into pre-market and post-market regulatory submissions and decisions.” The Framework report “A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology” was published in May 2015.
What has the project produced so far?
- A framework for incorporating information on those preferences into benefit-risk assessments of new medical technology.
- A catalog of methods that can be used to assess patient preferences about the benefits and risks of a medical technology.
- An analysis of gaps in current methods for assessing patient preferences.
- An agenda for further research. Download report here.
What are some of the ongoing and upcoming projects for the Science of Patient Input Committee?
- A project to integrate patient preferences into the statistical design of clinical trials
- New initiatives to integrate patient input into clinical trial design and collection of longitudinal data
Who is working on this project?
MDIC has assembled a steering committee of member organization and FDA representatives, patient advocates, and other experts to guide work on this project.