NIH, FDA Release Streamlined Clinical Trial Protocol Template

Regulatory NewsRegulatory News | 18 March 2016 |  By 

In an effort to increase the efficiency of clinical trial protocol reviews, the National Institutes of Health (NIH) has released a draft protocol template developed in collaboration with the US Food and Drug Administration (FDA).

The draft protocol, developed by the NIH-FDA Joint Leadership Council (JLC), will apply to NIH-funded Phase II and III clinical trials done in support of an investigational new drug application (IND) or investigational device exemption (IDE).

The new template has the potential to "help clinical investigators make clinical trials more efficient, potentially saving development time and money," Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), writes in a post on the agency's blog FDA Voice.

According to Marks, the new template will help fill a gap left by international standards for drug and device trials, referring to the International Council for Harmonisation's E6 Good Clinical Practice: Consolidated Guidance and the International Organization for Standardization's (ISO) Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (ISO 14155:2011).

"Although guidance provides information on the important content that should be included in a protocol to help ensure human subject protection and data quality, it does not describe a standardized format for presenting this information," he writes.

Additionally, Marks says that a standardized format is needed because "up to 85% of investigators have only participated in one clinical trial in their careers [and] many investigators lack significant experience in protocol development," citing recent data on investigators who completed FDA's Statement of Investigator form (Form 1527).

While the draft template is aimed specifically at investigators developing clinical trial protocols for NIH-funded studies, Marks says that FDA hopes to one day collaborate with similar efforts, such as the common protocol template developed by TransCelerate Biopharma, "to help ensure consistency for the medical product development community."

The draft template is available from NIH with instructions and examples included, and as a blank template with the instructions and examples removed.

Both agencies are calling for input on the utility of the template from investigators, sponsors, institutional review board members and others involved in the development of clinical trial protocols.

NIH/FDA Draft Clinical Trial Protocol Template


FDA Voice, NIH Under the Poliscope


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