TY - JOUR
T1 - Chronic graft-versus-host disease
T2 - Implications of the National Institutes of Health consensus development project on criteria for clinical trials
AU - Pavletic, S. Z.
AU - Lee, S. J.
AU - Socie, G.
AU - Vogelsang, G.
N1 - Funding Information:
The National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD was supported by the National Cancer Institute, Office of the Director, Cancer Therapy Evaluation Program, Intramural Research Program, and Center for Cancer Research; National Heart Lung and Blood Institute, Division of Blood Diseases and Resources; Office of Rare Diseases, NIH, Office of the Director; National Institute of Allergy and Infectious Disease, Transplantation Immunology Branch; and the Health Resources and Services Administration, Division of Transplantation and the Naval Medical Research Center, CW Bill Young/Department of Defense Marrow Donor Recruitment and Research Program. The authors would also like to acknowledge the following organizations that by their participation made this project possible: American Society for Blood and Marrow Transplantation, European Group for Blood and Marrow Transplantation, Center for International Bone and Marrow Transplant Research, Blood and Marrow Transplant Clinical Trials Network, Canadian Blood and Marrow Transplant Group and Pediatric Blood and Marrow Transplant Consortium. The organizers are also indebted to patients and patient and research advocacy groups who made this process much more meaningful by their engagement. The project group recognizes contributions of numerous colleagues in the field of blood and marrow transplantation, medical specialists and consultants, pharmaceutical industry, and the National Institutes of Health and US Food and Drug Administration professional staff for their intellectual input, dedication, and enthusiasm.
Funding Information:
The Chronic GVHD Consensus Project was sponsored by the intramural and extramural programs of the National Cancer Institute, National Heart Lung and Blood Institute, and National Institute for Allergy and Infectious Disease, the NIH Director’s Office, the Health Resources and Services Administration, and the Department of Defense, and the Naval Medical Research Center. The FDA representatives were involved as a major goal was the development of new therapies for chronic GVHD. The first planning meeting was held in June 2004 and included transplant investigators with a focus on chronic GVHD, consultants, and representatives of government agencies. Six working groups were formed: diagnosis and staging of chronic GVHD, histopathology, biomarkers, response criteria, supportive care, and design of clinical trials. These groups were inclusive to ensure their work reflected consensus opinion. It was clear from the outset that there were insufficient data to provide evidence-based recommendations. Thus, the reports of these groups represent the best expert opinion.
PY - 2006/11
Y1 - 2006/11
N2 - Chronic graft-versus-host disease (GVHD) has been a difficult problem to address and clinical research in this area lags behind other innovations in hematopoietic stem cell transplantation (HCT). Recently the international transplant community has focused more on chronic GVHD. This new focus is well represented by the development of the National Institutes of Health sponsored chronic GVHD consensus project, which has unified the transplant community's approach to chronic GVHD through the activities of focused working groups. From December 2005 through May 2006, a series of consensus documents have been published addressing the areas of diagnosis and staging, histopathology, strategies for the development and validation of biomarkers, response criteria, ancillary therapy and supportive care and the design of clinical trials. This paper summarizes and discusses these reports, focusing specifically on diagnosis and scoring and response criteria. Although these documents represent a huge effort by the research community, they must be prospectively implemented and validated. These new criteria should advance the standards and uniformity of chronic GVHD clinical research. The ultimate success of this project is dependent on whether these recommendations move the field forward. This is an opportunity for the transplant community to unite and make a significant impact in chronic GVHD.
AB - Chronic graft-versus-host disease (GVHD) has been a difficult problem to address and clinical research in this area lags behind other innovations in hematopoietic stem cell transplantation (HCT). Recently the international transplant community has focused more on chronic GVHD. This new focus is well represented by the development of the National Institutes of Health sponsored chronic GVHD consensus project, which has unified the transplant community's approach to chronic GVHD through the activities of focused working groups. From December 2005 through May 2006, a series of consensus documents have been published addressing the areas of diagnosis and staging, histopathology, strategies for the development and validation of biomarkers, response criteria, ancillary therapy and supportive care and the design of clinical trials. This paper summarizes and discusses these reports, focusing specifically on diagnosis and scoring and response criteria. Although these documents represent a huge effort by the research community, they must be prospectively implemented and validated. These new criteria should advance the standards and uniformity of chronic GVHD clinical research. The ultimate success of this project is dependent on whether these recommendations move the field forward. This is an opportunity for the transplant community to unite and make a significant impact in chronic GVHD.
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U2 - 10.1038/sj.bmt.1705490
DO - 10.1038/sj.bmt.1705490
M3 - Review article
C2 - 16980994
AN - SCOPUS:33750547108
SN - 0268-3369
VL - 38
SP - 645
EP - 651
JO - Bone marrow transplantation
JF - Bone marrow transplantation
IS - 10
ER -