Ecancermedicalscience. 2014 Jan 16;8:387. eCollection 2014.
The ethics of clinical trials.
Author information
- Foundation and Ethics of the Life Sciences (FOLSATEC), Department of Health Sciences, University of Milan, Italy.
Abstract
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 regulated enterprises that have to
comply with ethical
requirements while maintaining high epistemic standards, a balance that
becomes increasingly difficult as the research questions become more
sophisticated. In this review, the author will discuss some of the most
important ethical issues surrounding RCTs, with an eye to the most recent debates and the context of oncological research in particular.
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