Clinical trials and ethics

The ethics of clinical trials

Over the past decades, randomised controlled trials (RCTs) have prevailed over clinical judgement, case reports, and observational studies and became the gold evidential standard in medicine. Furthermore, during the same time frame, RCTs became a crucial part of the regulatory process whereby a new therapeutic can gain access to the drug market. Today, clinical trials are large and tightly regu...

Ethics of randomised clinical trials.

Up to now there are no generally accepted ethical guidelines for controlled studies. The issue is hardly discussed in the Helsinki Declaration even in its last version. The reason might be that in many of these studies it is difficult to determine whether to classify them as 'mere patient-care' or as research. If they are to be considered as mere patient-care, the doctor is under the obligation...

Ethics and statistical methodology in clinical trials.

Statisticians in medicine can disagree on appropriate methodology applicable to the design and analysis of clinical trials. So called Bayesians and frequentists both claim ethical superiority. This paper, by defining and then linking together various dichotomies, argues there is a place for both statistical camps. The choice between them depends on the phase of clinical trial, disease prevalenc...

Exploitation and the ethics of clinical trials.

The ethics of global clinical trials

C linical research by academic institutions and pharmaceutical companies has followed the general trend of globalization and has moved inexorably towards lowand middle-income countries (LMIC). This trend has raised various concerns, including whether the research being conducted is of value to public health in these countries or whether economically disadvantaged populations are being exploited...