Speeding up the evaluation of new agents in cancer.
Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.
Parmar
Mahesh K B
MK
Clinical Trials Unit, London, UK. mp@ctu.mrc.ac.uk
Barthel
Friederike M-S
FM
Sydes
Matthew
M
Langley
Ruth
R
Kaplan
Rick
R
Eisenhauer
Elizabeth
E
Brady
Mark
M
James
Nicholas
N
Bookman
Michael A
MA
Swart
Ann-Marie
AM
Qian
Wendi
W
Royston
Patrick
P
D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000068258:Bevacizumab; D002986:Clinical Trials as Topic / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D018572:Disease-Free Survival; D017277:Drug Approval; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy; D000077150:Oxaliplatin; D011471:Prostatic Neoplasms / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D018401:Sample Size; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000068258:Bevacizumab