Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 18 March 2016 | By Michael Mezher
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
Tags: NIH-FDA Joint Leadership Council, Clinical trial protocol template