The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database.

The Clinical Trials Information System (CTIS), an online portal for submission and review of clinical trial data, went live on Jan. 31, 2022, allowing researchers, sponsors and regulators as well as patients and the general public, to view and search trial data (CenterWatch Weekly, Feb. 27).

The request for comment takes the form of an anonymous survey, released May 5, that asks for respondents’ opinions on the types of structured data and documents that are critical for publication, and whether delay of data publication or redaction of information should be used to protect commercial confidentiality.

The EMA also released an interim guidance that provides a stopgap approach to CTIS data privacy protection that will be in effect until the agency finalizes its transparency rules. The guidance advises trials to submit two versions of their data: “not for publication” on the publicly searchable database, which would include personal data needed for scientific and regulatory review; and “for publication,” containing only anonymized trial data. It also provides guidance on the principles of data anonymization.

Responses to the survey are due June 28. The EMA expects to issue a final rule on CTIS transparency by the end of 2023.

Access the survey here: https://bit.ly/3nwTPZ4.

Read the interim guidance here: https://bit.ly/3VzyESE.