Format

Send to

Choose Destination
Leukemia. 2008 Feb;22(2):231-9. Epub 2007 Nov 1.

Clinically relevant end points and new drug approvals for myeloma.

Author information

1
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. kenneth_anderson@dfci.harvard.edu

Abstract

This manuscript summarizes the recommendations of the American Society of Hematology/US Food and Drug Administration Workshop on Clinical Endpoints in Multiple Myeloma, which brought together clinical investigators in multiple myeloma, the United States Food and Drug Administration, pharmaceutical companies, patient advocates and other concerned scientists and physicians to provide guidance, consensus and consistency in the definition of clinically relevant end points to expedite new drug approvals for multiple myeloma in the appropriate trial design settings. This manuscript will therefore be a most valuable resource to provide the framework for the design of appropriate clinical trial strategies for more rapid new drug approval in myeloma.

PMID:
17972944
DOI:
10.1038/sj.leu.2405016
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Nature Publishing Group
Loading ...
Support Center