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In September 2020 a broad cross-disciplinary coalition of medical societies and patient advocates issued the joint statement ‘Reducing bureaucracy in clinical trials: now is the time!’ Action Kidney Cancer is a member of this coalition aimed at reducing bureaucracy in clinical trials.
The statement calls for urgent action to make clinical trials less bureaucratic and more patient-centred, efficient and cheaper. At stake are the quality of clinical trials, access to innovative treatments and, crucially, patient safety.
The Coalition calls on regulators, policymakers, sponsors, ethics committees and other stakeholders to collaborate to make sure regulatory guidelines, safety reporting requirements and informed consent procedures do not harm what they are meant to protect: clinical trial quality and patient safety.
These Coalition Recommendations for Reducing Bureaucracy in Clinical Trials aim to mitigate the risks identified by investigators and patients, proposing a number of actions grouped in four different clusters:
- Safety Reporting,
- Informed Consent,
- Regulatory guidelines
- Harmonisation of requirements across the EU.
Read the consensus statement and call to action here: Reducing Bureaucracy in Clinical Trials – An ongoing call for action
If you would like to know more about the work of the coalition, please email us.