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Am J Transplant. 2019 Mar;19(3):625-632. doi: 10.1111/ajt.15214. Epub 2019 Jan 23.

The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement.

Author information

1
Mayo Clinic, Rochester, Minnesota.
2
Sanofi Genzyme, Medical Affairs, Cambridge, Massachusetts.
3
Terasaki Research Institute, Los Angeles, California.
4
University of Alabama at Birmingham, Birmingham, Alabama.
5
Houston Methodist, Houston, Texas.
6
Transplant Genomics Inc., Mansfield, Massachusetts.
7
Comprehensive Transplant Center, Northwestern University, Chicago, Illinois.
8
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
9
Astellas Pharma Global Development, Inc., Northbrook, Illinois.
10
Emory University School of Medicine, Atlanta, Georgia.
11
Stanford University School of Medicine, Stanford, California.
12
Duke University, Durham, North Carolina.
13
Critical Path Institute, Tucson, Arizona.

Abstract

The Transplant Therapeutics Consortium (TTC) is a public-private partnership between the US Food and Drug Administration and the transplantation community including the transplantation societies and members of the biopharmaceutical industry. The TTC was formed to accelerate the process of developing new medical products for transplant patients. The initial goals of this collaboration are the following: (a) To define which aspects of the kidney transplant drug-development process have clear needs for improvement from an industry and regulatory perspective; (b) to define which of the unmet needs in the process could be positively impacted through the development of specific drug-development tools based on available data; and (c) to determine the most appropriate pathway to achieve regulatory acceptance of the proposed process-accelerating tools. The TTC has identified 2 major areas of emphasis: new biomarkers or endpoints for determining the efficacy of new therapies and new tools to assess the safety or tolerability of new therapies. This article presents the rationale and planned approach to develop new tools to assess safety and tolerability of therapies for transplant patients. We also discuss how similar efforts might support the continued development of patient-reported outcome measures in the future.

KEYWORDS:

clinical trial design; editorial/personal viewpoint; immunosuppressive regimens; kidney transplantation/nephrology; mathematical model; organ transplantation in general; quality of life (QoL); side effects; translational research/science

PMID:
30549395
DOI:
10.1111/ajt.15214

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