May 2021: Statement on transparency and data integrity by ICMRA and WHO

Joint Statement on transparency and data integrity – International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)

New guidance from the EU tells sites and sponsors of medical device trials how to communicate with regulators about trial progress, submit safety reports, request permission for protocol amendments and draft trial summary reports under the new Medical Device Regulation (MDR) scheduled to take effect on May 26.

The 19-page document from the union’s Medical Device Coordination Group (MDCG) answers such questions as whether sponsors of trials conducted in one or more EU member states need to notify regulators of the end of the trial in each country.

The common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making. The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base.

In addition to enhance patient understanding about the clinical trials in which they have participated, biopharmaceutical companies are collaborating with national regulatory authorities to adopt mechanisms for providing lay summaries of clinical trial results to research participants consistent with applicable laws and rules.

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