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:

• • Agenda and Attendees
  • MDIC Overview | Jon Hunt, MDIC
  • MDIC Initiative on Early Feasibility Studies | Chip Hance, MDIC
  • FDA Perspectives on Early Feasibility Studies | Maureen L. Dreher, FDA

• Presentations I- Best Practices Sponsor Perspective
• • Sponsor 1: Edwards Lifesciences | Laura de la Cruz
  • Sponsor 2: preCARDIA | Sara Vidmar
  • Sponsor 3: Medtronic | Christy Malone
  • Sponsor 4: Conformal Medical | Chris Cain
  • Sponsor 5: Abbott | Felicia Jones

• Presentations II- Best Practices Site Perspective
• • Site 1: Northwestern | Anna Huskin
  • Site 2: Baylor, Scott, & White Research Institute | Kristen Chionh
  • Site 3: Mayo Clinic | Michelle Monosmith
  • Site 4: MedStar | Rebecca Torguson

Conclusions & Next Steps | Chip Hance, Jaime Walkowiak, Liliana Rincon-Gonzalez

Full Event PDF Packet:

• •  2020 EFS Best Budgeting Practices Materials