Data monitoring committees, ethical

Data monitoring committees face difficult ethical challenges, in particular deciding whether a clinical trial should be terminated early. 

Before 1990, clinical trials conducted in Russia were characterized by a number of peculiarities. Many trials had no protocol and were carried out following the recommendations of the MOH. No ethics committees existed. There was no communication between the sponsor and the investigator, and the latter had no idea about the monitoring or audits, as if no such things existed. Moreover, the clinical data (study reports) would go directly to the Pharmacological Committee without being circulated to the sponsor. 

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