FDA/NIH Final Protocol Template Could Boost Trial Efficiency

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A year in the making, the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) just unveiled a final version of a template for investigators to use when organizing clinical trial protocols.

Calling it a roadmap for conducting a trial, Center for Biologics Evaluation and Research Director Peter Marks, MD, noted that the template is designed for Phase II and Phase III NIH-funded studies requiring investigational new drug (IND) or investigational device exemption (IDE) applications to the FDA.

The new template “is likely to contribute to important efficiencies to the process of protocol development, saving medical development time and money,” Marks said.

A robust standard protocol development is also expected to facilitate review of protocols by regulators and institutional review boards (IRBs), among others.

The NIH/FDA Joint Leadership Council template is harmonized with the separate protocol template recently adopted by TransCelerate Biopharma for industry-sponsored research.

The final template could also be used by investigators conducting studies of medical products not under FDA’s regulatory umbrella, Marks said.

Author: Michael Causey