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EMA to set up technical group in the context of the publication of clinical data

Friday, March 24, 2017

The EMA has launched a call for applications to join a technical anonymization group (TAG) that will help the Agency to further develop best practices for the anonymization of clinical reports. The goal is to set up a multidisciplinary team with a broad range of expertise.

As of October 2016, the EMA gives open access to clinical reports on medicines under phase I of its policy on the publication of clinical data (EMA Policy 0070). This requires the anonymization of reports in line with European personal data protection law.

Anonymization of clinical reports poses a major challenge to those directly involved (pharmaceutical industry, clinical research organizations and EMA) and to those accessing the data (patients, healthcare professionals and academia). The Agency has already published comprehensive guidance on the anonymization of the reports. However, as data anonymization is a rapidly evolving field, EMA wants to keep abreast of developments and continue to update the guidance with the support of experts.

The proposed technical group will consider the experience gained with the publication of clinical reports from the first phase of the implementation of EMA’s publication of clinical data policy. It will assess best anonymization practices, and any risks to privacy and re-identification of patients in the light of new technological developments. In addition, it will investigate how the anonymization methodology used impacts the scientific utility of the published data, and establish whether secondary analysis of the data can be successfully undertaken.

To address these challenges, the group will be composed of data protection experts, experts in re-analysis of clinical data from academia, industry professionals with direct experience in the anonymization of clinical data, professionals developing de-identification standards and guidance, and representatives of patient and healthcare professional organizations.

Individuals interested in becoming members of the TAG can consult the group’s terms of reference in annex to the call for applications, and should send their CV and the declaration of interests form to tag@ema.europa.eu by 28 April 2017.

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