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Start Date: 9/22/22
Start Time: 8:00 AM ET
AbOUT:
This public workshop will be focusing on 1) qualifying a composite surrogate for long-term graft loss after kidney transplantation 2) real-world evidence (RWE) use in transplant clinical trials and 3) potential future endpoints in kidney transplantation
The Transplant Therapeutics Consortium (TTC) aims to accelerate the medical product development process for transplantation by identifying challenges, prioritizing solutions, and developing tools to advance new product development to meet the most pressing needs of transplant recipients.
AGENDA:
| Welcoming remarks |
Amanda Klein and Ozlem Belen |
Session 1: Qualifying a composite surrogate for long-term graft loss after kidney transplantation
- 1A - Regulatory qualification procedures and qualification status of the iBox Scoring System as a reasonably likely surrogate endpoint with FDA
- 1B - Graphical user interface for sample size calculation using iBox scores
- Panel discussion
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Speakers: Amanda Klein and Luke Kosinski
Moderator: William E. Fitzsimmons |
Session 2: Real-world evidence (RWE) use in transplant clinical trials
- 2A - Sample size calculation and need for RWE supplemental external controls for the 5-year survival analyses
- 2B - Pilot study for external control using the cyclosporine arm of the BENEFIT RCT versus UNOS/OPTN registry data
- 2C - Regulatory and design considerations for RWE supplementation in transplant clinical trials
- Panel discussion
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Speakers: Luke Kosinski, Alice Toll, and John Concato
Moderator: Amanda Klein |
Session 3: Future endpoints in kidney transplantation
- 3A - Efficacy endpoints
- 3B - Safety endpoints
- 3C - Regulatory qualification procedures for clinical outcome assessments
- 3D - Patient-reported outcome measures for transplantation
- Panel discussion
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Speakers: Peter Nickerson, William E. Fitzsimmons Rebecca Speck, and Dave Taber
Moderator: Mark Stegall |
| Closing Remarks |
Amanda Klein, Kenneth Newell, and Ulf Meier-Kriesche |
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Speakers
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Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government source(s), totaling $11,196,634. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
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