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Chronic Graft-versus-Host Disease-Implementation of the National Institutes of Health Consensus Criteria for Clinical Trials. / Griffith, Linda M.; Pavletic, Steven Z.; Lee, Stephanie J.; Martin, Paul J.; Schultz, Kirk R.; Vogelsang, Georgia B.In: Biology of Blood and Marrow Transplantation, Vol. 14, No. 4, 04.2008, p. 379-384.
Research output: Contribution to journal › Comment/debate › peer-review
TY - JOUR
T1 - Chronic Graft-versus-Host Disease-Implementation of the National Institutes of Health Consensus Criteria for Clinical Trials
AU - Griffith, Linda M.
AU - Pavletic, Steven Z.
AU - Lee, Stephanie J.
AU - Martin, Paul J.
AU - Schultz, Kirk R.
AU - Vogelsang, Georgia B.
N1 - Funding Information: Availability of funding support for studies in cGVHD has been extremely limited. The standard NIH Research Project (R01) format may not be a good fit for applications in cGVHD that need a multicenter or interdisciplinary clinical trials design. For cGVHD in particular, the relatively small number of cases, with lack of clear assignment of responsibility to a single NIH Institute/Center (IC) presents an additional challenge in applying for and successfully obtaining NIH funding. However, even in this era of relative fiscal constraint for the NIH, using the National Institute of Allergy and Infectious Diseases (NIAID) as an example, over half of the annual budget of the Division of Allergy, Immunology and Transplantation (DAIT) remains available for investigator-initiated research, representing a significant opportunity  . It may be reasonable to consider cooperation of NIH ICs having a direct or partial interest in cGVHD studies, or support through existing networks or other consortia, when developing a funding plan for large cooperative clinical trials. A Program Project (P01) approach may be appropriate. Interactive discussions with U.S. Government funding agencies should be pursued, to promote intramural and extramural NIH and government-wide collaborations where feasible. Investigators should approach NIH ICs with their proposals for joint ventures. It is likely that the NIH would view collaborative efforts that result in elimination of redundant funding or cost saving as advantageous. Opportunities for funding other than NIH should be considered, including other U.S. Government agencies, such as, for example, the Food and Drug Administration (FDA) Office of Orphan Products Development, as well as private foundations such as the Biomarkers Consortium of the Foundation for the NIH, and others. Funding Information: The opinions expressed are those of the authors and do not represent the position of the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health, or the U.S. Government. This workshop was sponsored by the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the Office of Rare Diseases, National Institutes of Health, Bethesda, MD.
PY - 2008/4
Y1 - 2008/4
UR - http://www.scopus.com/inward/record.url?scp=40649105286&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=40649105286&partnerID=8YFLogxK
U2 - 10.1016/j.bbmt.2008.01.005
DO - 10.1016/j.bbmt.2008.01.005
M3 - Comment/debate
C2 - 18342779
AN - SCOPUS:40649105286
VL - 14
SP - 379
EP - 384
JO - Biology of Blood and Marrow Transplantation
JF - Biology of Blood and Marrow Transplantation
SN - 1083-8791
IS - 4