Regulatory News

EMA Seeks Experts on Clinical Data Anonymization

The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.

"Anonymisation 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)," EMA says.

Specifically, EMA says it plans to form a new committee, referred to as the Technical Anonymisation Group (TAG), to assist the agency in fleshing out best practices for anonymizing the data in clinical study reports.

The call comes just months after EMA adopted guidance detailing its recommendations for anonymizing and redacting clinical data in accordance with its policy for proactive publication of clinical data that went into effect in October 2016.

Under the policy, EMA plans to release clinical study reports for all clinical trials submitted to the agency, regardless of whether the product is ultimately authorized, rejected or withdrawn.

However, one of the biggest challenges the agency faces with the policy is ensuring it protects patient and commercially confidential data.

For patient data, EMA says it must not only be anonymized, but that cannot be re-identified later.

According to the agency, the TAG will focus on assessing these practices, as well as determining any impacts to the scientific utility of the data as a result of the anonymization.

EMA