In May 2009, scientific leaders gathered for a full-day workshop entitled, “Workshop on Clinical Trial Endpoints for Acute Graft-vs-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation”. The purpose of this workshop was to review data that will serve as the foundation for protocol design and clinical trial evidence-based endpoints intended to support the approval of new drugs or biologics to prevent or treat acute GVHD.
Workshop topics included:
- Regulatory issues related to GVHD trials
- Diagnosis and grading of acute GVHD
- Endpoints for acute GVHD prevention trials
- Endpoints for acute GVHD treatment trials
- Statistical ways to minimize confounding factors
- Biomarkers for acute GVHD
- Patient-reported outcomes for acute GVHD trials
Access the workshop agenda and slides.
This workshop was co-sponsored by the National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Food and Drug Administration (FDA), Center for International Blood and Marrow Transplant Research (CIBMTR), American Society for Blood and Marrow Transplantation (ASBMT) and National Institute of Allergy and Infectious Diseases (NIAID).