Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: a tutorial

The aim of phase II single-arm clinical trials of a new drug is to determine whether it has sufficient promising activity to warrant its further development. For the last several years Bayesian statistical methods have been proposed and used. Bayesian approaches are ideal for earlier phase trials as they take into account information that accrues during a trial. Predictive probabilities are then updated and so become more accurate as the trial progresses. Suitable priors can act as pseudo samples, which make small sample clinical trials more informative. Thus patients have better chances to receive better treatments. The goal of this paper is to provide a tutorial for statisticians who use Bayesian methods for the first time or investigators who have some statistical background. In addition, real data from three clinical trials are presented as examples to illustrate how to conduct a Bayesian approach for phase II single-arm clinical trials with binary outcomes.

The dynamics of threat, fear and intentionality in the conduct disorders: longitudinal findings in the children of women with post-natal depression

This paper considers how environmental threat may contribute to the child's use of avoidant strategies to regulate negative emotions, and how this may interact with high emotional reactivity to create vulnerability to conduct disorder symptoms. We report a study based on the hypothesis that interpreting others' behaviours in terms of their motives and emotions - using the intentional stance - promotes effective social action, but may lead to fear in threatful situations, and that inhibiting the intentional stance may reduce fear but promote conduct disorder symptoms. We assessed 5-year-olds' use of the intentional stance with an intentionality scale, contrasting high and low threat doll play scenarios. In a sample of 47 children of mothers with post-natal depression ( PND) and 35 controls, children rated as securely attached with their mothers at the age of 18 months were better able to preserve the intentional stance than insecure children in high threat scenarios, but not in low threat scenarios. Girls had higher intentionality scores than boys across all scenarios. Only intentionality in the high threat scenario was associated with teacher-rated conduct disorder symptoms, and only in the children of women with PND. Intentionality mediated the associations between attachment security and gender and conduct disorder symptoms in the PND group.

A coherent procedure for inferring conduct

We exploit a theory of price linkages that lends itself readily to empirical examination using Markovchain, Monte Carlo methods. The methodology facilitates classification and discrimination among alternative regimes in economic time series. The theory and procedures are applied to annual series (1955-1992) on the U.S. beef sector