The Coalition calls on regulators, policymakers, sponsors, ethics committees and other stakeholders to collaborate to ensure that regulatory guidelines, safety reporting requirements and informed consent procedures do not harm what they are meant to protect: clinical trial quality and patient safety. Over the past year, the Coalition has developed a series of concrete and consensus-based recommendations for reducing administrative burdens in clinical trials, laid out below in four clusters: safety reporting, informed consent, regulatory guidelines, and harmonisation of requirements across the EU.

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