The European Medicines Agency (EMA) now provides open access to clinical reports under phase I of its policy on the publication of clinical data (EMA Policy 0070), which also requires report anonymization in line with European personal data protection law.
As Outsourcing-Pharma.com previously reported, the regulation is the European Union’s (EU) “central instrument to achieve transparency.”
To learn more about TAG, Outsourcing-Pharma.com talked with the EMA about what it hopes to achieve and how industry stakeholders can participate.
Why did the EMA decide to launch TAG?
Proactive publication of clinical data under Policy 0070 is a completely new activity for EMA and for all those involved. As a result, the Agency released in March 2016 external guidance covering the anonymisation of clinical reports amongst various topics.
The field of anonymisation, and in particular the techniques used by controllers of personal data to anonymise data, is a rapidly evolving field of research.
Therefore, anonymisation poses a major challenge for all parties involved in the anonymisation of clinical reports (pharmaceutical industry, clinical research organisations and EMA) as well as for those wanting to access the data (patients, academics and healthcare professionals).
What is the group’s goal?
The Agency has now identified the need to continue the work undertaken during the development and finalisation of the external guidance on the anonymisation of clinical reports for publication and will seek input from EMA experts in the field by setting up a TAG.
The overall objective of the TAG is to establish best practices for the anonymisation of clinical reports by monitoring and addressing any issues arising in the context of the implementation of phase I of policy 0070.
Who do you expect potential members to be?
The TAG will be composed of a maximum of 20 members with a broad range of expertise. Members must have a university degree and demonstrated relevant professional experience, either in the health sector, research/academia, or in the areas of data protection and/or data privacy.
They should have proven experience in data privacy in healthcare, anonymisation of clinical data, and/or re-analysis of clinical data.
EMA will ensure a balanced representation of relevant know-how and a diverse representation of the various stakeholders (academics, industry, healthcare professionals, patients, etc.).
What has been the initial response?
We have had six applications in the first week.
What are the guidelines for joining?
Those interested who meet the eligibility criteria should submit a detailed CV (but not exceeding three pages) and declaration of interests. The Agency will then choose the appropriate candidates based on the selection criteria and a balanced representation of all stakeholders.
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 email@example.com by 28 April 2017.