The European Medicines Agency (EMA) has published new guidance for pharmaceutical companies on how to comply with its policy on the publication of clinical data. The guidelines address how to prepare and submit clinical study reports (CSRs), including how to anonymise data, and how to identify and redact commercially confidential information.
CSRs are very long documents that contain detailed information about the methods and results of clinical trials. They contain crucial information about the effectiveness and safety of treatments that might otherwise go unpublished.
Under its policy the EMA will proactively publish the final redacted versions of CSRs submitted in companies’ applications for approval to market medicines, 60 days after a decision has been made. The policy came into effect on 1st January 2015; publication of the first reports is expected mid-September 2016.
Tracey Brown, Director, Sense about Science, co-founder of AllTrials, said:
“Some pharmaceutical companies are already publishing clinical study reports and finding that there is very little that is commercially confidential. Unfortunately, other less transparent companies have used fear-mongering about confidentiality to create a stalemate with the European regulator. EMA’s new guidance might now put an end to that stalemate. But the definition of what is commercially confidential has been hard to pin down, not least because some in the sector want it kept broad. So we urge the EMA to look very closely at how companies start applying these exemptions.”
Matthew Herder, Associate Professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, said:
“This policy has the potential to make the EMA the most transparent regulator in the world. The policy requires companies to provide release-ready versions of CSRs to the EMA for public consumption. This has the potential to provide unprecedented, proactive access to CSRs and the data they contain. But the devil — as always — lies in the details. If industry takes a liberal view of what information can be redacted and/or the EMA does a poor job of enforcing the definition of ‘commercially confidential information’ it has set, these release-ready versions of CSRs may prove far less useful than we hope. So we’ll have to say tuned to see how ground breaking this policy really proves to be.”
Peter Doshi, Assistant Professor of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, and Associate Editor of The BMJ, said:
“There is a lot to like about the EMA’s new guidance to industry. The document confirms EMA’s commitment to the publication of important sections of CSRs such as the main body report, the protocol and amendments, statistical analysis plan, and sample case report forms. Having these documents publicly available a short time after regulatory decision making concludes could very well be the beginning of a new era in regulatory transparency and accountability. But readers need to be aware of the scope. CSR appendices containing individual participant data are considered outside the scope of this guidance and are slated to be handled in a future Phase of the policy. It remains unclear where EMA will land in terms of acceptable anonymization standards and I remain wary that some approaches may render individual participant data useless.”