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Clinical trial rules should protect patients

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Rules governing the conduct of clinical trials are failing to produce the intended benefits for patients and should be rewritten through a transparent process that involves academic clinical trialists and patient advocates as well as regulators and industry representatives, according to recommendations published in European Heart Journal. The call comes from the Cardiovascular Round Table (CRT), an independent forum of the European Society of Cardiology (ESC), which convened regulators, drug companies, academic clinical trialists and patients to discuss the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. “Well conducted randomised clinical trials are the bedrock of safe and

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