Trial Design

Drugmakers Say Changes to Informed Consent Will Confuse Patients

An FDA draft guidance that would require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs would confuse patients so much that recruiting subjects for clinical trials will become nearly impossible, drugmakers argue. Read More

Amarin Loses Latest Appeal for Vascepa SPA

The FDA has again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product. Read More

ICH to Develop Guideline on Multiregional Trials

Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More