This is a collective and urgent appeal by medical associations and patient advocates across disciplines to all involved – in particular, policymakers and regulators at EU and national levels, ethics committees and the pharmaceutical industry – to agree on risk-based pragmatic simplification measures to address the issues of “Inappropriate and counterproductive safety reporting”, “Inadequate informed consent and reconsent” and “Overinterpretation of regulations and guidelines”. The shared goal must be a substantial reduction of bureaucratic obstacles in clinical trials, not (only) as a response to current exceptional circumstances, but on a permanent basis. Do you support this appeal? Join our coalition.
Overview of the signatories per May 2023
* Signatory is a member of the BioMed Alliance