New clinical trial template will 'save time and money'

The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) have published their final version of a template for investigators to use when organizing clinical trial protocols.

A confident Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, predicts that this roadmap will contribute to ‘important efficiencies to the process of protocol development, saving medical product development time and money’.

It is for use by those writing protocols for Phase II and Phase III NIH-funded trials requiring investigational new drug or investigational device exemption applications, and could also be helpful to other investigators conducting studies of medical products that are not regulated by the FDA.