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...

The accounts of medical trials provide very detailed information about the patients’ health conditions. On the contrary, almost no vital data such as marital status or age distribution are usually given. Yet, some of these factors can have a notable impact on the overall death rate, thereby...

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...

Objective: The objective of the study was to compute a cost-effectiveness ratio relating the economic cost of trandolapril to the number of effectiveness units (i.e. life-years) gained. Design and Setting: The trandolapril cardiac evaluation (TRACE) study was a prospective placebo-controlled...

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...

In 2001, the ACM and IEEE Computing Curriculum stated that it was necessary to address "the need to develop implementation models that are international in scope and could be practiced in universities around the world." With increasing connectivity through the internet, the move towards a global...

This paper discusses how household panels in general?and the German Socio- Economic Panel (SOEP) in particular?can serve as reference data for researchers collecting datasets that do not represent the full universe of the population of interest (e.g., through clinical trials, intervention...

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...

The globalization of biopharmaceutical clinical trials and their offshore outsourcing, from the West to low and middle-income countries, has come under increasing scrutiny from academic scholars, practitioners, regulatory agencies and the media. This article reports the results of a study...