title: Clinically relevant end points and new drug approvals for myeloma.
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.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA. kenneth_anderson@dfci.harvard.edu
authors.forename: K C
authors.initials: KC
authors.lastname: Anderson
authors.forename: R A
authors.initials: RA
authors.lastname: Kyle
authors.forename: S V
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: A K
authors.initials: AK
authors.lastname: Stewart
authors.forename: D
authors.initials: D
authors.lastname: Weber
authors.forename: P
authors.initials: P
authors.lastname: Richardson
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000379:methods*; D023381:Endpoint Determination; D006801:Humans; D009101:Multiple Myeloma / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration