October 19, 2019
On June 12, 2019, MDIC partnered with the Cardiovascular Research Foundation (CRF), to host an EFS symposium focused on best practices among clinicians for patient screening and enrollment in Early Feasibility Studies. The key focuses of the event included presentations on:
- Identification of relevant patient population/Patient screening
- Patient consent
- Procedural and clinical follow-up issues
Presentations from the event are now available for viewing.
January 24, 2019
On May 18, 2018, MDIC convened a workshop to discuss the outcomes and next steps for its patient-centered outcomes research (PCOR) project in Parkinson’s Disease (PD). The project was a nearly two-year collaboration with the Michael J. Fox Foundation for Parkinson’s Research, FDA CDRH, MIT, and RTI Health Solutions to investigate how patient preferences could be used to set statistical significance levels in a clinical trial design.
April 1, 2019
Home hemodialysis device manufacturer, NxStage, used the MDIC Patient-Centered Benefit-Risk (PCBR) Framework as a guide in developing a patient preference survey to quantify the acceptable risk of hemodialysis home alone versus at a dialysis center. Data from that survey were taken into consideration in FDA CDRH’s decision to clear an expanded indication for NxStage’s home hemodialysis device – the first 510(k) clearance in which quantitative patient preference data played a role.
Current as of October 25, 2019
1655 N Ft. Myer Drive, 12th Floor
Arlington, VA 22209
202-828-1600
Arlington, VA 22209
202-828-1600