Publication details

Principy klinických studií

Title in English Principles of clinical trials
Authors

VÍTOVEC Jiří ŠPINAR Jindřich

Year of publication 2014
MU Faculty or unit

Faculty of Medicine

Citation
Description The design and conduct of clinical trials is another challenging area. Because of safety concerns and regulatory requirements, companies have grown wary of ambitious and costly programmes. Models where new drugs may be approved conditionally with re-assessment of drug label and/or licence after completion of ambitious post-marketing surveillance programmes and genuine phase IV safety trials should be encouraged. Within this context, obsession with morbidity/mortality endpoints should be abandoned.
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