Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma.

Say-Beng Tan, Y-F Alexander Chung, Bee-Choo Tai, Yin-Bun Cheung, David Machin
Author Information
  1. Say-Beng Tan: Division of Clinical Trials & Epidemiological Sciences, National Cancer Centre, Singapore, Singapore. ctetsb@nccs.com.sg

Abstract

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.

MeSH Term

Bayes Theorem
Carcinoma, Hepatocellular
Clinical Trials, Phase III as Topic
Disease-Free Survival
Endpoint Determination
Humans
Iodine Radioisotopes
Iodized Oil
Liver Neoplasms
Radiotherapy, Adjuvant
Randomized Controlled Trials as Topic
Research Design
Sample Size

Chemicals

Iodine Radioisotopes
Iodized Oil

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