The paper deals with the Bayesian sequential analysis of clinical trials and the related predictive approach in a particularly innovative fashion. We propose a unified methodology for sequential clinical trials under a Bayesian paradigm. The idea is to make predictive inference based on the data...

Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number...

Experimental design represents the typical context in which the interplay between Bayesian and frequentist methodology is natural and useful. Before the data are observed, it is licit and unavoidable even for a Bayesian statistician to take into account sample variability for the evaluation of...

Disclosing overall scientific results to clinical trial participants has become an ethical obligation. Here we studied how participants understand these results in view of their experience of clinical trials and illness in general and what modes of disclosure they preferred. Interviews were...

Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible...

The article examines the role and challenges of scientific self-governance and standardization in inter-continental clinical research partnerships in stem cell medicine. The paper shows that – due to a high level of regulatory diversity – the enactment of internationally recognized standards...

XXX

The issue of balance between research and treatment in clinical trials conduct has been surrounded by controversies. Scientific characteristics of trials may compromise medical care available to participants, while conceiving research participation as having therapeutic value may foster the...

An urn contains balls of d = 2 colors. At each time n = 1, a ball is drawn and then replaced together with a random number of balls of the same color. Let An =diag (An,1, . . . ,An,d) be the n-th reinforce matrix. Assuming EAn,j = EAn,1 for all n and j, a few CLT’s are available for such urns....

Simulation of realistic censored survival times is challenging. Most research studies use highly simplified models, such as the exponential, that do not adequately reflect the patterns of time to event and censoring seen in real datasets. In this article, I present a general method of simulating...