Clinical trial design in hepatocellular carcinoma.
Researchers interested in developing treatments for hepatocellular carcinoma (HCC) face three sets of problems; one set common to all clinical trialists at the beginning of the 21st century, one set related to phase I/II studies ('early drug development') and one set related to the design of phase III (randomised, controlled trials). This review is concerned with the challenges faced in designing high quality clinical trials in patients with HCC. Specific published trials are not discussed other than by way of illustration of the problems faced.
Johnson
Philip J
PJ
Institute for Cancer Studies, University of Birmingham, Vincent Drive, Edgbaston, Birmingham B15 2TT, UK. p.johnson@bham.ac.uk
Billingham
Lucinda J
LJ
D006528:Carcinoma, Hepatocellular / Q000473:pathology; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology; D009367:Neoplasm Staging; D016032:Randomized Controlled Trials as Topic; D012107:Research Design