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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

02/03/2015

Pubmed ID

25639771

DOI

10.1016/j.bbmt.2014.12.030

Scopus ID

2-s2.0-84924237100   12 Citations

Abstract

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 CF

Authors

Marcelo C. Pasquini MD, MS Professor in the Medicine department at Medical College of Wisconsin
Wael Saber MD, MS Associate Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Clinical Trials as Topic
Costs and Cost Analysis
Guidelines as Topic
Hematopoietic Stem Cell Transplantation
Humans
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a