U.K. DoH wants clarity on proposed clinical trial legislation

The U.K. Department of Health asked for clarity on what data would be published under proposed changes to the EU's clinical trial regulations. The European Parliament has been working on legislation that would make it easier for sponsors to conduct multinational clinical trials in Europe. In May, a parliamentary committee passed an amendment to the legislation that would require the publication of full clinical study reports within 30 days of when a decision on marketing authorization -- whether positive or negative -- has been made.

The DoH said it agrees the clinical study reports should not be considered commercially confidential once a regulatory decision is made, but said "it is important that there is clarity about the data that should be included in clinical study reports." In March, the EU Parliament is scheduled to take up the proposal. ...