FDA Updates the Clinical Protocol Template
(Thursday, January 19, 2023)
The FDA recently released an updated clinical protocol template designed for electronic documentation practices. This update provides additional instructions and suggestions for the various elements of clinical protocols to harmonize information needed for electronic information exchanges such as clinical trial registries. The template can be used for all stages of clinical trials for drugs, biologics, vaccines, cell or gene therapy products, as well as drug-device combination products regulated as a drug (i.e., approved under an NDA or a BLA). Although not explicitly stated, the template can also be used for most medical device trials. There used to be a significant variability in the format of the written clinical protocols based on sponsors’ experience and training. This variability is much more relevant from review of the formats of the information posted on clinicaltrials.gov registry. A few years ago, FDA and NIH released a joint clinical protocol template to harmonize clinical protocol writing. Additionally, the clinicaltrials.gov registry added detailed requirements and logic checks to assure harmonized publishing of protocol in its registry. The updated template is designed to further that goal of harmonizing clinical protocols. The new template contains much greater amount of boilerplate content, suggested texts and detailed instructions for each section of the protocol. The accompanying ICH M11 technical guidance document goes even further and adds instructions which could be used to create software for automating protocol writing. The NIH has already created a free tool to automate the protocol writing which takes away most of the guess work out of protocol writing. The template, called as “Clinical Electronic Structured Harmonized Protocol” intends to represent core set of information for a clinical trial, encourage consistency and unambiguity, increase electronic information exchange, while maintaining flexibility. So, that brings an important question; can clinical protocol writing be automated entirely? Short answer, while tools like this make it easier to format protocols, the basic design and customization of parameters based on scientific questions still need to be done by a person.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC