Sample Size Requirements and Study Duration for Testing Main Effects and Interactions in Completely Randomized Factorial Designs When Time to Event is the Outcome.

In this paper we develop the methodology for designing clinical trials with any factorial arrangement when the primary outcome is time to event. We provide a matrix formulation for calculating the sample size and study duration necessary to test any effect with a pre-specified type I error rate and power. Assuming that a time to event follows an exponential distribution, we describe the relationships between the effect size, the power, and the sample size.

Estimation and testing of the relative risk of disease in case-control studies with a set of k matched controls per case with known prevalence of disease.

The analysis of case-control studies with matched controls per case is well documented in the medical literature. Of primary interest is the estimation of the relative risk of disease. Matched case-control studies fall into two scenarios: the probability of exposure is constant within each of the case and control groups, or the probability of exposure varies within each group.

Odds ratios for a continuous outcome variable without dichotomizing.

The loss of information from dichotomizing a continuous outcome is well documented in the literature. One advantage of dichotomizing is that it allows estimation of odds ratio parameters through a logistic regression analysis. The objective of this paper is to develop a new estimator of the same odds ratio parameters through regression analysis on the original continuous outcome without the inherent loss of information caused by dichotomizing.