Significant Endpoints, Unified Hypothesis Pressed in Guidance on International Clinical Trials

When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance.

Developed over the past two years by the International Conference on Harmonisation, the guidance makes several recommendations to drugmakers looking to file simultaneous marketing applications.

The guidance suggests that using a unified trial hypothesis, with common comparators, can increase the chances of acceptance by global regulatory authorities.