Publications
- November 21, 2023
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October 16, 2023
Transforming Drug Development for Neurological Disorders: Proceedings from a Multidisease Area Workshop
Diane Stephenson, Ramona Belfiore-Oshan, Yashmin Karten, Jessi Keavney, D. Kevin Kwok, Terina Martinez, Joe Montminy, Martijn L. T. M. Müller, Klaus Romero & Sudhir Sivakumaran Neurological disorders represent some of the most challenging therapeutic areas for successful drug approvals. The escalating global burden of death and disability for such diseases represents a significant worldwide public health challenge, and the rate of failure of new therapies... -
October 11, 2023
Applying propensity methods to the United States transplant registry for external real-world evidence control arms for 5-year survival in the BENEFIT study
Amanda Klein, Alice Toll, Darren Stewart, William E. Fitzsimmons Abstract To address the challenges of assessing the impact of a reasonably likely surrogate endpoint on long-term graft survival in prospective kidney transplant clinical trials, the Transplant Therapeutics Consortium established a real-world evidence workgroup evaluating the scientific value of using transplant registry data as an external... -
September 25, 2023
Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes
Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche, Roslyn B. Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O’Doherty, Ahmed Osama Gaber, William E. Fitzsimmons. on behalf of the Transplant Therapeutics Consortium Abstract New immunosuppressive therapies that improve long-term graft survival are... -
September 25, 2023
Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes
Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche, Roslyn B. Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O’Doherty, Ahmed Osama Gaber, William E. Fitzsimmons. on behalf of the Transplant Therapeutics Consortium Abstract New immunosuppressive therapies that improve long-term graft survival are...
