Ethics of randomised clinical trials.

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...

Equipoise, consent and the ethics of randomised clinical trials

A doctor has a duty to give his patient what he believes to be the best treatment. An ethical prerequisite of recommending her to enter a randomised clinical trial (RCT), in which his patient will be randomly allotted to one of two or more treatments, is, as Michael Baum in his chapter stresses, that he is ignorant about their relative efficacy and, hence, justifiably indifferent as to which sh...

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...

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...

Exploitation and the ethics of clinical trials.