Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials. Biol Blood Marrow Transplant 2015 Apr;21(4):583-8
Date
02/03/2015Pubmed ID
25639771DOI
10.1016/j.bbmt.2014.12.030Scopus ID
2-s2.0-84924237100 (requires institutional sign-in at Scopus site) 15 CitationsAbstract
The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation.
Author List
Majhail NS, Giralt S, Bonagura A, Crawford S, Farnia S, Omel JL, Pasquini M, Saber W, LeMaistre CFAuthors
Marcelo C. Pasquini MD, MS Professor in the Medicine department at Medical College of WisconsinWael Saber MD, MS Professor in the Medicine department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
Clinical Trials as TopicCosts and Cost Analysis
Guidelines as Topic
Hematopoietic Stem Cell Transplantation
Humans