Following the MDIC’s EFS Site Best Practices workshop in March 2019, Martin Leon, MD (Columbia University Medical Center), Aaron Kaplan, MD (Dartmouth-Hitchcock, Serial Entrepreneur), Michael Mack, MD (Baylor), Chip Hance (Regatta Medical) and David R. Holmes, Jr., MD (Mayo Clinic), conceived a meeting focused on the issues of Early Feasibility Studies from the clinicians’ perspective. Specifically, the meeting focused on the following three areas:
●Identification of relevant patient population/Patient screening
●Patient consent
●Procedural and clinical follow-up issues
The program addressed these specific topics with different presentations followed by robust audience participation for discussion with clinical investigators and industry sponsors. This program took place on Wednesday, June 12, 7:00-9:30 pm, at the Sheraton Grand in Chicago.
This event was sponsored by MDIC in collaboration with CRF.
Panelists Include:
• Howard C. Herrmann, Penn Medicine
• Vinod Thourani, Medstar Heart and Vascular Institute
• Michael Mack, Baylor Scott & White
• Scott Lim, University of Virginia
• Bernard Vasseur, FDA
Event Materials:
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.
Individual Event Materials:
- Symposium Agenda and Attendees
- EFS Symposium: Implementation Strategies for Early Feasibility Studies | David R. Holmes, Jr., MD, Mayo Clinic
- MDIC Introduction and Program Update, Pamela Goldberg | MDIC, Chip Hance | MDIC EFS Initiative Board Champion
- Topic # 1: Identification of relevant patient population/Patient screening, Scott M. Chadderdon, MD | OHSU | Blessie Concepcion | Boston Scientific
- Topic # 2: Patient consent, Charles J. Davidson, MD, FACC, FAHA, FSCAI | Northwestern Jill Trekell | Edwards Lifesciences
- Topic # 3: Procedural and clinical follow-up issues, Tamim Nazif, MD | Columbia, Chris Cain | Conformal Medical, Inc.
- Conclusions
Full Event PDF Packet:
EFS Symposium at TVT 2019 PDF Packet
This online training course was developed to provide users with a high-level overview of the proposed Corrective and Preventive Action (CAPA) process, including insights for auditors.
MDIC held its final Case for Quality Forum of 2019 on November 6 in Arlington, VA. Download slides from the forum below.
Welcome and Introductions
MDIC Case for Quality Overview
Strategic Foresight Session
Panel Discussion: VIP and Expansion
Download CDRH Slides
Download CMMI Slides
Presentation: MDIAS SafeSpace
Advanced Manufacturing Working Group Update
Fixing CAPA Working Group Update
VIP Working Group Update
NCS Pilot Working Group Update
Debrief and Q&A
Closing Remarks and Next Steps
February 26, 2020
In 2017 and 2019, MDIC collected metrics in the first ever collaborative sharing of Sponsor administrative data. Average time from the site packet received at the site to first patient enrolled was improved from 320 days to 252 days thanks to improvements in IRB review cycles and more timely first patient enrollment. However, contract negotiations between sponsors and sites – and more specifically reaching agreement on a study budget – actually worsened from an average of 133 days to 164 days. Reaching agreement on a contract and budget, a purely administrative (yet, critical) task in clinical trial setup is taking nearly six months in back and forth between sponsors and sites thereby delaying the actual performance of the clinical study.
MDIC has collaborated in two workshops with Baylor Scott & White Research Institute to develop an EFS Master Clinical Trial Agreement (MCTA) template to help sponsors and sites streamline this aspect of contracting. EFS Study Sponsors who have used the agreement report that contract negotiations based on the MDIC MCTA template have enabled some contract negotiations to be completed in as little as a month – a dramatic improvement.
MDIC sought to bring the same effort on improving the efficiency of sponsor-site budget negotiations as has been demonstrated in contracting. Budget negotiations are consistently troublesome and rank the highest of issues to address to streamline EFS studies going forward. On February 26, 2020 in Arlington, VA, MDIC led a workshop of leading sponsors and sites with extensive EFS experience to share EFS budgeting best practices and roundtable discussions to identify concrete improvement steps that can be taken.
The objectives for the one-day workshop were:
• Share leading sponsor and leading site best practices for timely and efficient EFS budget negotiations
• Consolidate these best practices and determine as a group those approaches that will make the biggest differences across the landscape of sites and sponsors
• Establish a working group from interested participants who want to standardize budgeting approaches and communicate them throughout the medical device clinical trial ecosystem
Workshop Materials:
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.
Individual Event Materials:
- Presentations I- Best Practices Sponsor Perspective
- Presentations II- Best Practices Site Perspective
Conclusions & Next Steps | Chip Hance, Jaime Walkowiak, Liliana Rincon-Gonzalez
Full Event PDF Packet:
The NESTcc Methods Framework is applicable to many different data sources and defines the key components of a study protocol for the evaluation of medical devices.
The document promotes overall study design, outlining principles to follow and evidentiary requirements for core elements including disease and device information, target population and patient selection, study outcomes and procedures, sample size, monitoring and statistical analysis.
The NESTcc Data Quality Framework focuses primarily on the use of EHR data in the clinical care setting, and considers topics including data governance, characteristics, capture, transformation, and curation.
Within the framework, the NESTcc Data Quality Maturity Model addresses the varying stages of an organization’s capacity to support these domains, which allows collaborators to indicate progress toward achieving optimal data quality.
Parkinson’s patients Margaret Sheehan and Anne Cohn Donnelly, who participated as Patient Scientists on the MDIC Patient Centered Outcomes Research project team along with representatives from the Michael J. Fox Foundation for Parkinson’s Research (MJFF), the U.S. Food and Drug Administration (FDA), and MIT, provide their perspectives on how clinical researchers can best engage with patients in this white paper.