NIH-FDA Draft Clinical Trial Protocol Template: Stakeholder Feedback Needed!

In the recently released NIH-Wide Strategic Plan (FY 2016-2020), the agency declared our commitment to “fostering approaches to enhance the speed and efficiency with which [clinical] trials are conducted.” On March 17, we unveiled a piece of that ongoing effort for input from stakeholders: a draft clinical trial protocol template released in today’s Guide to Grants and Contracts.

Developed jointly by NIH and the Food and Drug Administration (FDA), the protocol template  provides a standard format with instructional and sample text that NIH funded investigators can use when preparing protocols for phase 2 or 3 clinical trials that require an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) application.

The agencies’ goal in developing the template is to ensure investigators prepare protocols that are organized consistently and contain all the information necessary to enable efficient and timely review.   The draft template is consistent with guidance on protocol development found in the International Conference on Harmonisation (ICH) E6 Good Clinical Practice.  A copy of the draft template as well as instructions on how to comment can be viewed on the NIH OSP Website.

We encourage stakeholders to submit comments on the utility of the template and the clarity of the accompanying instructional guidance.  We would specifically welcome feedback from investigators, investigator-sponsors, institutional review board members, and any other stakeholders who are involved in protocol development and review on the readability and clarity of the instructions contained in the template.  Stakeholder feedback will be critical when NIH and FDA consider the next steps in this process.

Posted by Dr. Carrie D. Wolinetz, March 18, 2016

Comments (2):

    When going through the template, those people that are familiar with the CDISC standards will notice that 80-90% of the contents of the template is covered by the CDISC CTR-XML, SDM-XML, ODM and CDISC Controlled Terminology standards. However, CDISC is not even mentioned in the accompanying documents. The template together with the CDISC standards gives us the opportunity to develop a machine-readable, even machine-executable (like automated study setup, automated SDTM-TD generation etc.) protocol that is at the same time human-editable and human-readable. In order to do so, we will however have to move away from MS-Word (not a vendor-neutral standard) and probably need to move to XML (or similar). Some volunteers within CDISC and Phuse will soon start such an effort.

Leave a Reply

Your email address will not be published. Required fields are marked *