Detecting a treatment-biomarker interaction, which is a task better suited for large sample sizes, in a phase II trial, which has a small sample size, is challenging. In this paper, we investigate how two plausibly available sources of historical data may contain partial information to help estimate the treatment-biomarker interaction parameter in a randomized phase II study. The parameter is n...

Sir, It is observed that the clinical trials published in various medical journals are poor in reporting of various methodological aspects, including sample size calculation and power. It is difficult to generalize the results of clinical trials having poor reporting of statistics to the normal patient population and conducting these clinical trials raises ethical issues. It is always advisable...

Zhao and Tsiatis (1997) consider the problem of estimation of the distribution of the quality-adjusted lifetime when the chronological survival time is subject to right censoring. The quality-adjusted lifetime is typically defined as a weighted sum of the times spent in certain states up until death or some other failure time. They propose an estimator and establish the relevant asymptotics und...

While the number of clinical trials performed yearly is increasing, the application of these results to individual patients is quite difficult. This article reviews key portions of the process of applying research results to clinical practice. The first step involves defining the study population and determining whether these patients are similar to the patients seen in clinical practice in ter...

Distribution of some statistics, especially rank based, with censored data are hard to get. Even if they can be worked out for small samples, they are likely to be prohibitively expensive for larger sample sizes. Therefore we need to work on the asymptotic distribution which often works well for moderate and large sample sizes. This notes is intended to be read along with Fleming and Harrington...

Resampling-based expression pathway analysis techniques have been shown to preserve type I error rates, in contrast to simple gene-list approaches that implicitly assume the independence of genes in ranked lists. However, resampling is intensive in computation time and memory requirements. We describe accurate analytic approximations to permutations of score statistics, including novel approach...

We describe a tolerance interval approach for assessing agreement in method comparison data that may be left censored. We model the data using a mixed model and discuss a Bayesian and a frequentist methodology for inference. A simulation study suggests that the Bayesian approach with noninformative priors provides a good alternative to the frequentist one for moderate sample sizes as the latter...

The main purpose of investigational phase II clinical trials is to explore indications and effective doses. However, as yet, there is no clear rule and no related published literature about the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched for clinical trials in the ClinicalTrials.gov registry using the keywords "dose-finding" or "dose-respon...