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NIH, FDA Create Clinical Trial Template for Precision Medicine

In anticipation of more clinical trials thanks to breakthroughs in precision medicine, the FDA and NIH are providing additional guidance to the research community.

By Jennifer Bresnick

- As the Precision Medicine Initiative starts to increase the amount and scope of medical research, the National Institutes of Health (NIH) and FDA are seeking public comment on a draft template that provides guidance to investigators looking to document the results of their clinical trials.

Clinical trials and the Precision Medicine Initiative

The template providers a framework for researchers to present their findings and relevant data in a clean and standardized manner, making it easier for peers to review, understand, and analyze research results.

“The clinical trial protocol is a critical component of any medical product development program,” wrote Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research in a blog post last week, and “enhancing important efforts around clinical trials continues to be a key scientific priority.”

The FDA and NIH are responsible for a large portion of the sprawling Precision Medicine Initiative, and already oversee much of the research ecosystem that has sprung up around advances in personalized therapies, genomic testing and treatment, and other breakthrough advances to treat common and rare diseases alike.

In addition to overseeing many clinical trials and approval processes for new drugs and medical devices, the FDA and NIH are working to create a national precision medicine database, which hopes to include data on at least one million patients who are representative of the population at large.

Researchers will be able to access the information in the databank once it reaches sufficient size, and the resulting wealth of big data will no doubt bring a measurable spike in clinical trials and other research programs.

The two agencies are constantly looking for “ways to help clinical investigators make clinical trials more efficient, potentially saving development time and money,” Marks said, and are paying particular attention to phase 2 and phase 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications.

Since up to 85 percent of investigators have only participated in one clinical trial during their careers, the FDA and NIH have the opportunity to provide inexperienced researchers with a structured way to present information.

“Time spent identifying the specific elements that should be included in a protocol and how best to organize them can delay the start of a clinical trial, and lead to delays in getting important new treatments to patients,” Marks explains.  The newly introduced framework hopes to give researchers will less experience a head start on this difficult aspect of conducting a study.

However, the template is not intended to be a mandated guideline, the FDA stressed.  Researchers are free to borrow from the template, but are not required to adhere to it in every particular.

“We see the template as a way to facilitate creativity and innovation, not inhibit it,” said Marks. “In the words of our NIH colleague Dr. Pamela McInnes, ‘Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them.’”

“The template includes the appropriate elements to be considered, but does not dictate exactly how the trial should be done—that is the work of the investigators.”

The document, developed by representatives from both agencies, includes guidance on how to create comprehensive and meaningful summaries, flowcharts and process diagrams, study design data, and conclusions.

“Our agencies hope that the availability of the template and instructional information enables investigators to prepare protocols that are consistent and well organized, contain all the information necessary for the clinical trials to be properly reviewed, and follow the ICH E6 Good Clinical Practice guidance,” Marks said. “Better organized, high-quality protocols will also expedite the review process at both agencies.”

The NIH and FDA are accepting public comment through April 17, 2016.  Depending on the feedback received, the agencies may consider developing an “online, step-by-step protocol template tool to dynamically guide users through steps to write a clinical trial protocol,” the NIH website says. 


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