The NESTcc has selected the first-round of Demonstration Projects that address several key use-cases to demonstrate the feasibility and value of generating Real World Evidence for clinical studies across the Total Product Life Cycle.
Selected NESTcc Demonstration Projects
The selected Demonstration Projects test two approaches to leveraging Real-World Data and generating Real-World Evidence: The first project is focused on developing an electronic health record (EHR) based network in a large hospital system to support evidence generation for medical devices across the Total Product Life Cycle (TPLC). The second project tests the feasibility of using a mobile health (mHealth) application that aggregates multiple sources of health data, with patient consent, to augment post-market surveillance.
While these projects make use of data generated post-approval, the methods have the potential to produce generalizable knowledge to inform requirements and decisions in the pre-market phases and potentially across multiple medical device classes and medical technologies such as imaging and diagnostics. We believe that these initial projects will:
- Help develop methods of evidence generation and data use
- Scale across health systems, device types, and small and large manufacturers
- Potentially demonstrate impact on patients’ health outcomes, and better engage patients in research
- Identify gaps to help target critical areas and inform NESTcc’s strategy moving forward
None of these projects will provide a competitive advantage to a specific manufacturers. Furthermore, NESTcc will not provide funding for the core research activities for these Demonstration Projects, as the projects are already funded and underway but will work collaboratively with the project teams to establish learnings and resources for NESTcc as we move forward.
The Selection Process
These projects were selected through an open, public call followed by a rigorous review process that was approved by the MDIC Executive Committee on July 25, 2017. NESTcc received a robust set of submissions from across the medical device ecosystem, some of which will be reconsidered for future Demonstration Project designation.
During the Demonstration Project review:
- Each application was reviewed by two to three reviewers (including clinical and industry perspectives where possible)
- Reviews were used by the NESTcc Executive Director to make a recommendation to the Selection Team (a subset of the NESTcc Governing Committee)
- Reviewers each completed conflict of interest disclosures prior to reviewing and Selection Team members completed conflicts of interest disclosures in accordance with the MDIC conflict of interest policy. In addition:
- Reviewers and Selection Team members did not review or provide input to projects in which they had a conflict
- The steps taken to address conflict of interest issues were reviewed and deemed appropriate by legal counsel
Additional details on the selection process are available in a recent blog post by the Executive Director on August 29, 2017.
What Comes Next?
NESTcc will continue the open call for Demonstration Projects, including active outreach to stakeholders, from large and small companies, to submit appropriate projects in the pre-market space and post-market space over the next few months. We are particularly interested in hearing from you if you are working in the fields of imaging and diagnostics, if you have projects using RWD/RWE to support label expansions, or label modifications. We’re also very interested in working with small companies and with projects that have multiple sponsors. Please email the NESTcc if you would like to discuss a proposal before submitting it. The next deadline for submissions is November 1, 2017. Details on the application process are available on our website.