Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials Journal Article
| Authors: | Majhail, N. S.; Giralt, S.; Bonagura, A.; Crawford, S.; Farnia, S.; Omel, J. L.; Pasquini, M.; Saber, W.; Lemaistre, C. F. |
| Article Title: | Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials |
| 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. © 2015 American Society for Blood and Marrow Transplantation. |
| Keywords: | follow up; practice guideline; hematopoietic stem cell transplantation; transplantation; health care policy; health care quality; patient care; clinical research; clinical trials; costs; hematopoietic cell transplantation; randomized controlled trial (topic); clinical trial (topic); phase 2 clinical trial (topic); phase 3 clinical trial (topic); standard of care; course evaluation; routine care; affordable care act; human; article |
| Journal Title: | Biology of Blood and Marrow Transplantation |
| Volume: | 21 |
| Issue: | 4 |
| ISSN: | 1083-8791 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2015-04-01 |
| Start Page: | 583 |
| End Page: | 588 |
| Language: | English |
| DOI: | 10.1016/j.bbmt.2014.12.030 |
| PROVIDER: | scopus |
| PUBMED: | 25639771 |
| DOI/URL: | |
| Notes: | Export Date: 2 April 2015 -- Source: Scopus |
