Catching Up With Data Disclosure

With the European Union's new rules on clinical trials—including data access—approaching their final legislative stage, and the European Medicines Agency planning to announce its new rules on data disclosure within weeks, the European drug industry is still running to catch up with transparency issues.

On April 4, the full European Parliament is scheduled to back the clinical trials deal that its health committee struck late last year with national governments after more than eighteen months of intensive discussions. All that will then be needed is a formal sign-off by the EU member states at a meeting of the Council of Ministers (by now a mere formality), and the EU will have its new system for clinical trials on the statute book. And the EMA will reveal the final version of its plans for proactive publication of clinical-trial data, immediately after its management board endorses the document at its June meeting.

Meanwhile, the European Federation of Pharmaceutical Industries and Associations has announced its own moves towards giving wider access to clinical trials data. On March 24 it published an update on industry progress on the 'Principles for Responsible Clinical Trials Data Sharing' that it adopted (jointly with PhRMA) last year, and which came into force at the start of this year.

So far, the on-the-record industry action comprises initiatives by nine multinationals.

Last December already, Pfizer detailed its updated policy on clinical trials data sharing, which EFPIA says meets the principles.  The same month, MSD, Roche, and UCB indicated the steps they are taking towards implementing the principles. In January this year, Sanofi announced its plans to expand clinical trials data sharing through participation in http://clinicalstudydatarequest.com, a multi-company portal for clinical trial data sharing. Other companies participating in this portal include GSK, Boehringer Ingelheim, and Roche. In March, Novo Nordisk launched a web platform where clinical study reports are now published and through which secondary researchers can seek access to detailed anonymized data. Johnson & Johnson has also recently announced that its subsidiary, Janssen Research and Development, will enter an agreement with Yale School of Medicine’s Open Data Access (YODA) Project.

Under the soon-to-be-finalized clinical trials rules, pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database. The parliament says that detailed summaries must be published in a publicly accessible EU database, with full clinical study reports published once a decision on marketing authorization for the tested product is complete or the marketing authorization application has been withdrawn.

The precise nature of disclosure under the EMA plans remains to be decided - and industry has been arguing vigorously that there should be due consideration for protecting sensitive data. The agency says only that efforts have been made "to identify redaction criteria for those parts of clinical-trial data that exceptionally contain commercially confidential information." It is also refining "a consultation process with the concerned data owners on user-friendly technical measures to make the data accessible under the new policy, whilst addressing the need to reasonably protect against unfair commercial use of the data."

In delivering the EFPIA announcement, Richard Bergstrom, its director general, said the industry is committed to increased sharing of its clinical trials data, adding "It is working in partnership with stakeholders to make sure this continues to happen in a responsible way.” The next few days and weeks will make a little clearer just how this happens—and how "responsible" the industry considers the way it happens.