The emperor's new clothes or the current practice of clinical trials for multiple myeloma in the USA.
Phase III clinical trials help define standard therapies by comparing the outcomes of a new (experimental) treatment arm to the best established (control) arm. Superior outcomes should only be defined in measures of patient benefit. Two recent trials for upfront therapy of patients with multiple myeloma (ECOG E1A00 and E4A03) failed to conform to traditional Phase III trial design. Consequently they failed to provide any useful scientific data.
Ballester
Oscar
O
Edwards Comprehensive Cancer Center, Marshall University, Huntington, West Virginia, USA. oscar.ballester@chhi.org
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D003907:Dexamethasone / Q000008:administration & dosage; D023381:Endpoint Determination; D019317:Evidence-Based Medicine; D006801:Humans; D000077269:Lenalidomide; D009101:Multiple Myeloma / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D012107:Research Design; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D014481:United States
D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide