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Review
. 2014 Jan 16:8:387.
doi: 10.3332/ecancer.2014.387. eCollection 2014.

The ethics of clinical trials

Cecilia Nardini  1
Affiliations
Review

The ethics of clinical trials

Cecilia Nardini. Ecancermedicalscience. .

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.

Keywords: RCTs; ethics; personalized medicine; precision medicine; research.

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References

    1. Jones JH. Bad Blood: The Tuskegee Syphilis Experiment, expanded edn. New York: The Free Press; 1993 [1981].
    1. The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under control council law. 1949. [14/10/13]. http://nuremberg.law.harvard.edu/php/docs_swi.php?%20DI=1&text=medical.
    1. World Medical Association. Declaration of Helsinki, 6th revision. 2008. [14/10/13]. http://www.wma.net/en/30publications/10policies/b3/
    1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Bethesda, MD: ERIC Clearinghouse; 1978. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. - PubMed
    1. Howick JH. The Philosophy of Evidence-Based Medicine. London: Wiley-Blackwell; 2011. - DOI

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