Ethics and Evidence: Is Evidence from Randomized Controlled Trials Necessary to Firmly Establish a New Therapy?

Part of the Synthese Library book series (SYLI, volume 426)


In this chapter, I explore ethical issues that may arise in conducting randomized controlled trials to test therapeutic hypotheses, and address the question of whether randomized controlled trials are always necessary to firmly establish a new therapy. I illustrate the ethical issues by discussing several studies of extracorporeal membrane oxygenation therapy in newborn infants, and subsequently describe two cases in which a new cancer therapy was firmly established without randomized trial data: combination chemotherapy and radiation therapy in cancer of the anal canal, and multi-drug chemotherapy for disseminated carcinoma of the testis. I conclude that considerable opinion exists that the primary duty of physicians (qua physicians) is to the patients under their care and that conducting research is secondary, notwithstanding the immense benefit of medical research to society. I also conclude that randomized controlled trial data are sometimes unnecessary when other convincing data are available.


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© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Birmingham Radiological GroupBirminghamUSA

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