Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma.
A randomized, controlled clinical trial of radioactive iodine tagged with lipiodol in patients with resected hepatocellular carcinoma was criticized for its early stopping and resulting small sample size. To clarify its results, a new, larger multicenter trial was therefore proposed. This paper describes the elicitation of the pretrial opinions of the investigators involved in the new trial and the construction of appropriate clinical and skeptical prior distributions based on their responses. The prior distributions provide a useful tool in assessing the state of equipoise before the start of the trial. They can also be used in Bayesian analyses, both at the interim stage(s) as well as at the end of the trial. We illustrate these analyses, assuming that the data resulting from the new trial was the same as that obtained in the earlier trial when it was stopped.
Tan
Say-Beng
SB
Division of Clinical Trials & Epidemiological Sciences, National Cancer Centre, Singapore, Singapore. ctetsb@nccs.com.sg
Chung
Y-F Alexander
YF
Tai
Bee-Choo
BC
Cheung
Yin-Bun
YB
Machin
David
D
D001499:Bayes Theorem; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000532:radiotherapy; D017326:Clinical Trials, Phase III as Topic / Q000379:methods / Q000706:statistics & numerical data*; D018572:Disease-Free Survival; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D007459:Iodized Oil / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000401:mortality / Q000532:radiotherapy; D018714:Radiotherapy, Adjuvant; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D012107:Research Design; D018401:Sample Size
D007457:Iodine Radioisotopes; D007459:Iodized Oil