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Journal of Pharmacology and Medicinal Chemistry

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Scientific-ethical evaluation of clinical studies

Author(s): Péter Arányi*

A rather long and tortuous road leads from an original discovery of a novel mechanism and of a new molecular entity (NME) to a new drug or treatment. The clinical part of development is strictly regulated and it is the responsibility of ethics committees to protect the rights, safety and wellbeing of human subjects involved in a clinical trial. It is explained in a concise manner through recent examples of multinational clinical trials evaluated by the Ethics Committee for Clinical Pharmacology, Hungary (ECCP), how that duty is done in real life at the level of initiation of clinical studies. ECCP is convinced that a clinical trial cannot be ethically acceptable if it is not based on high quality scientific background and is not correctly elaborated in all detail.

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