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Malaysian Journal of Medical Sciences
School of Medical Sciences, Universiti Sains Malaysia
ISSN: 1394-195X
Vol. 24, No. 4, 2017, pp. 1-4
Bioline Code: mj17042
Full paper language: English
Document type: Editorial
Document available free of charge

Malaysian Journal of Medical Sciences, Vol. 24, No. 4, 2017, pp. 1-4

 en Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators
Sasongko, Teguh Haryo; Othman, Nor Hayati; Nik Hussain, Nik Hazlina; Lee, Yeong Yeh; Abdullah, Sarimah; Husin, Azlan & Van Rostenberghe, Hans


  The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.

randomised controlled trial; placebo; research ethics; ethics; institutional review board; ethics committee

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