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FDA, NIH & Industry Advance Templates for Clinical Trial Protocols

Posted 03 May 2017

The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) on Tuesday released the final version of a common template for clinical trial protocols intended to save sponsors of NIH-funded Phase II and III studies both time and money.

"The FDA and NIH see protocol harmonization as an essential component to the accelerated delivery of medicines to patients. Having aligned templates will help enable health authorities to receive consistent, high-quality protocols, enable timely review and ultimately ensure trial participant safety," said FDA Center for Drug Evaluation and Research Director Janet Woodcock.

The template, a 60-page document complete with instructions, explanatory text and samples, follows International Conference on Harmonisation (ICH) E6 (R2) Good Clinical Practice guideline and is aligned with a template developed for industry by TransCelerate BioPharma.

While the development of the two templates began independently of one another, NIH, FDA and TransCelerate say they collaborated on the final product to ensure they were aligned.

"The history of it is really interesting," TransCelerate CEO Dalvir Gill told Focus. "These were two parallel initiatives, and when we realized that, we quickly came together with the NIH [and] FDA."

According to Gill, "a very significant portion—I believe I was told 80 plus percent—of what the two protocol templates were trying to get at was very, very similar."

However, the overall structure of the two templates is the same, Gill said there are variations in the lower-level headings owing to the different audiences the templates are intended to serve.

"The NIH-FDA template … is aimed at smaller, single-center type, investigator-led studies in Phase II and III, whereas the common protocol template that came out of TransCelerate is more geared toward industry studies that are multi-center, global or even single country in Phase I, Phase II, Phase III, etc," Gill said.

But, Gill said that having a harmonized structure will help address what he referred to as "constant tinkering" with the structure of clinical trial protocols.

Gill also said he believes the template will be embraced by industry. "I suspect that this protocol template will become fairly widely used, particularly since it carries a fair amount of credibility from the regulators, from the governmental institutions, and a very significant part of the industry," he said, referring to TransCelerate's 18 members, including biopharmaceutical companies Pfizer, Johnson & Johnson, Eli Lilly, GlaxoSmithKline and Bristol-Myers Squibb.

Coinciding with the agencies' announcement, TransCelerate announced the release of an updated version of its template.

"We wanted the version not to be just a Word document that people cut and paste … The team felt that this technology enabled version would actually ease its use and provide people with much easier access to the libraries and registries at the therapeutic level that they're going to be providing," Gill said.

NIH also announced the release of an electronic tool of their own, which is intended to help clinical investigators collaborate with one another while developing trial protocols.

"We like to think of this as a sort of 'Turbo Tax' for clinical trial protocols. The tool allows for a collaborative approach to writing and reviewing protocols," writes Carrie Wolinetz, associate director for science policy at NIH.

FDA Voice, NIH, TransCelerate


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