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Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement
John R Greenland1, Michael Perch2, Kieran Halloran3
1Department of Medicine, University of California San Francisco, San Francisco, CA.
Summary
Standardizing clinical trial endpoints for lung transplantation, including primary graft dysfunction (PGD) and chronic lung allograft dysfunction (CLAD), aims to accelerate new therapy development. These consensus recommendations improve trial design and patient outcomes.
Area of Science:
- * Pulmonary Medicine & Transplant Surgery
- * Clinical Trial Design & Methodology
Background:
- * Lung transplantation clinical trials face challenges due to unclear endpoint definitions and significance.
- * Lack of standardized endpoints hinders therapeutic efficacy evaluation and drug development.
Purpose of the Study:
- * To establish consensus recommendations for key endpoints in lung transplantation trials beyond mortality.
- * To provide practical guidance for operationalizing and optimizing endpoint use in clinical research.
Main Methods:
- * A multidisciplinary working group convened by the International Society for Heart and Lung Transplantation.
- * Subgroups reviewed measurement best practices, clinical benefit links, and evidence for endpoints like PGD, CLAD, ACR, AMR, and PROs.
- * Consensus was achieved via a three-round Delphi process.
Main Results:
- * Recommendations developed for critical endpoints: primary graft dysfunction (PGD), chronic lung allograft dysfunction (CLAD), acute cellular rejection (ACR), antibody-mediated rejection (AMR), immunosuppression complications, patient-reported outcomes (PROs), and pediatric considerations.
- * Guidance provided on measurement, clinical utility, and trial application of these endpoints.
Conclusions:
- * Standardized endpoints will enhance lung transplantation clinical trial design and comparability.
- * These recommendations aim to expedite the development of novel therapies to improve long-term lung allograft survival and patient quality of life.
