Planning a Bayesian early-phase phase I/II study for human vaccines in HER2 carcinomas
Article first published online: 4 OCT 2010
Copyright © 2010 John Wiley & Sons, Ltd.
Volume 10, Issue 3, pages 218–226, May/June 2011
How to Cite
Zohar, S., Baldi, I., Forni, G., Merletti, F., Masucci, G. and Gregori, D. (2011), Planning a Bayesian early-phase phase I/II study for human vaccines in HER2 carcinomas. Pharmaceut. Statist., 10: 218–226. doi: 10.1002/pst.450
- Issue published online: 16 MAY 2011
- Article first published online: 4 OCT 2010
- phase I/II;
- Bayesian inference;
- prior distribution;
- dose finding
Recent innovative statistical approaches for phase I/II clinical trials allow one to jointly model the toxicity and efficacy of a new treatment, taking into account the information gathered during the trial. Prior probabilities are then updated with interim data and thus predictive probabilities become more accurate as the trial progresses. In this study, prior distribution elicited from a physician's opinion on the available dose levels planned for a vaccination dose-finding trial, with human DNA in patients with HER2-positive tumours in terms of toxicity and therapeutic response is presented and discussed. A simulation study was conducted in order to quantify the impact of the choice of prior on study results, i.e. the recommended dose level at the end of the trial. Copyright © 2010 John Wiley & Sons, Ltd.