Harmonized Protocol Templates Available for Clinical Trial Sponsors

TransCelerate BioPharma, FD3+A and NIH Common Template could save Phase II and III study sponsors time and money.

Clinical trial protocols are critical components of any drug development program because they include information on the organization, procedures and end goals of a study. To date, however, there has been no harmonized format for clinical trials protocols recognized by different agencies.

That has changed with the release of the final version of a common template for clinical trial protocols developed by the US FDA and the National Institutes of Health (NIH) in cooperation with TransCelerate BioPharma, an industry trade group that previously developed a template for industry. The template was issued by the NIH-FDA Joint Leadership Council.

Use of a standard protocol format that is recognized by regulators and government agencies and many leading pharmaceutical companies should facilitate protocol review, according to Dalvir Gill, CEO of TransCelerate.

FDA’s Center for Drug Evaluation and Research Director Janet Woodcock agrees, commenting, "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." 

The template development programs at FDA/NIH and TransCelerate were begun separately, but when the groups realized that their efforts paralleled one another, they quickly agreed to collaborate to ensure that the FDA/NIH template was fully aligned with the existing industry version.

The FDA/NIH template was released slightly more than one year after an initial draft was published by the two agencies. It is a 60-page document that includes instructions, explanatory text and samples and in addition to being aligned to the TransCelerate template, follows the International Conference on Harmonization (ICH) E6 (R2) Good Clinical Practice guideline. The recently released final version is intended for Phase II and Phase III NIH-funded studies requiring investigational new drug or investigational device exemption applications, according to FDA. TransCelerate also released an updated, technology-enabled, version of its template. In addition, NIH now offers an electronic tool designed to aid collaboration between clinical investigators while they are developing trial protocols.

Notably, while the structures of the two templates are the same, there are some differences in wording for certain section headings, largely due to the different audiences that the two documents are targeting. Specifically, the NIH/FDA template is expected to be used by smaller, single-center type, investigator-led studies, while the TransCelerate template targets larger, multi-center studies.

 “We believe that the template will help investigators prepare protocols that are consistent and well organized, contain all the information necessary for the clinical trial to be properly reviewed, and follow the ICH E6 Good Clinical Practice guidelines. By clarifying expectations, the template will contribute important time and money-saving efficiencies,” Gill states. He expects the industry will welcome the template because it was developed by FDA and NIH and also has approval from the 18 members of TransCelerate, which include leading pharma companies such as Pfizer, Johnson & Johnson, Eli Lilly, GlaxoSmithKline and Bristol-Myers Squibb.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.