Putting Regulatory Science to Practice for Medical Devices
What is the opportunity?
Demands for medical device evidence development addressing patient safety, therapeutic efficacy, and cost-benefit determinations are increasing. These evidence demands are well-documented drivers of medical device clinical trial size, complexity, timelines and costs. At the same time, and seemingly paradoxically, patient and provider demands for faster treatment access, and innovative treatment options are increasing. Given the legitimacy of these stakeholders’ data demands, combined with the realities of resource (budget and time) limitations, historical data acquisition techniques will soon no longer meet patient and provider needs.
While numerous solutions have been hypothesized in the literature, adoption of clinical trial solutions which both make clinical trials more efficient, and provide the data necessary to show safety and efficacy, has been scarce.
What is the Virtual Patient Working Group doing?
The Medical Device Innovation Consortium (MDIC) Virtual Patient (VP) working group has conducted retrospective clinical trial case studies leveraging the VP Model, developed and launched several methods, tools, and resources to facilitate VP Model implementation, and has developed and released the VP Model’s code in R, a free to the public repository for statistical code. In addition, ecosystem stakeholders have begun highlighting the VP Model independently of MDIC activities. This growth in activity and communication related to the VP Model is reflective of MDIC’s commitment, and that of our medical device ecosystem partners, to maximize clinical trial efficiency and improving patient access to cutting-edge medical technologies. Virtual Patient resources and tools include:
- Haddad T, Himes A, Thompson L. Incorporation of stochastic engineering models as prior information in Bayesian medical device trials. Journal of Biopharmaceutical Statistics 2017; http://dx.doi.org/10.1080/10543406.2017.1300907
- October 17th, 2016: Innovation in Clinical Trial Design to Reduce Trial Size. AdvaMed 2016 The MedTech Conference.
- February 20th, 2017: Leveraging Existing Information for Future Studies: The Case for Bayesian Methods. Cardiovascular Research Technologies (CRT) 2017.
- Faris O, Shuren J. An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials. The New England Journal of Medicine; 376:1350-1357; April 6, 2017; DOI: 10.1056/NEJMra1512592
- April 11th, 2017: AdvaMed Innovation Summit, Innovation in Clinical Evidence Generation, Synthesis and Appraisal to Advance Regulatory Science for the Total Product Life Cycle
- April 17th, 2017: MDICx – Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
- April 27th, 2017: Bayesian and Adaptive Designs. 10th Annual FDA/AdvaMed Medical Devices & Diagnostics Statistical Issues Conference.
- May 18th, 2017: Augmenting a Clinical Study with Virtual Patient Models: FDA and Industry Collaboration on a Mock Submission Sponsored by MDIC. BMES/FDA Frontiers in Medical Device Conference.
- May 18th, 2017: MDICx – Virtual Patient R Code Access and Use
- May 18th, 2017: MDICx – Virtual Patient R Code Release
- August 1st, 2017: Joint Statistical Meeting (JSM2017), Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments — Invited Papers Section on Medical Devices and Diagnostics
Integration of VP data within the clinical trial simplification framework has the power to revolutionize how device companies conduct clinical trials, sustain this paradigm shift, and satisfy patient and provider demands for safety, efficacy and improved access.