Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016.
The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers have notified EMA of the withdrawal of a marketing authorization application.
EMA held two meetings to offer more detailed discussions on two guidance documents under development -- one on the identification and redaction of commercially confidential information in the clinical reports and the other on the anonymization of clinical reports, in the context of the new policy.
"EMA emphasized that both guidance documents should be, once finalized, considered 'living' documents that will be updated in light of experience obtained," the agency said in a summary of the July meeting.
In the September meeting with patient associations, academia, representatives of National Competent Authorities and industry associations, EMA presented new technical guidance on the procedures tied to the submission of clinical reports, which included information on how trial materials should be sent to the agency, as well as information on the redaction consultation process and the overall process leading to publication.
The meeting centered on the "evolving nature of anonymization taking account of the objective of data utility and the legal requirements for personal data protection," EMA said.
"On one hand, if large sections of a clinical study report are removed, the risk of re-identification is likely to be very low but data utility will be compromised. On the other hand, if a clinical study report is ‘under’ redacted this could lead to the publication of documents that have a high risk of re-identification," the agency added.
The technical guidance on how data should be sent to EMA will now be sent to industry for consultation.
The agency said it will meet in October and consult with the European ombudsman and the European data protection supervisor on further plans for the transparency policy.
Other Data Sharing
In addition to the implementation of EMA's transparency policy, the European Commission, EMA and World Health Organization announced Tuesday that they agreed on 1 September to share more non-public information on the safety, quality and efficacy of already-approved drugs. The information they're sharing includes:
- post-authorization pharmacovigilance data, particularly related to adverse drug reactions as well as safety concerns arising from periodic safety update reports, and post-authorization obligations and commitments
- information in applications for scientific advice, orphan medicine designation, marketing authorization or post-authorization activities of significant public health interest, and applications for agreement of pediatric investigation plans
- data related to inspections, manufacturing facilities and clinical research activities and related reports
EMA September Stakeholder Meeting
Press Release on Trial Transparency
WHO, EC, EMA Sharing Press Release