NIH Invites Input on a Revised Clinical Trial Application Form to Reduce Burden and Enhance Review

We invite input by April 17, 2026 on a Proposed Clinical Trial-Specific Application Form (NOT-OD-26-058) for investigator-initiated clinical trials. The proposed form would combine essential details – currently spread across two forms – into a single, semi-structured yet flexible format designed to streamline applications, reduce burden for investigators, and improve the quality of peer review. 

Why are we making this change? 

If you’ve submitted clinical trial applications for NIH, you’ve probably had the experience of being asked for similar information in multiple places and in varying formats. If you’ve reviewed these applications, you’ve likely spent a lot of time searching through lengthy, unstructured, text to find the essential details needed for review.  

This happens because critical information is spread across the Research Plan and the Public Health Service (PHS) Human Subjects and Clinical Trials Information Form. That structure can create duplication, make it harder to find important information, and increase the workload for both applicants and reviewers. 

We’ve been working on ways to address these challenges for some time. And with NIH’s renewed commitment to reducing administrative burden, it prompted us to bring internal experts together to ask a simple question:  

• Can we make clinical trial applications easier for investigators and reviewers without losing critical information? 
• The answer was yes – and it led to a proposed revised approach with a straightforward goal: reduce burden, improve clarity, and make it easier for reviewers to assess the science. 

What is changing? 

The biggest change is this: Instead of distributing key information across multiple forms, we are proposing a single Proposed Clinical Trial–Specific Application Form that brings everything together in one place. 

• The proposed form consolidates that information into a single, semi-structured format, organized around how clinical trials are designed, reviewed, and conducted. 
• It is structured enough to improve clarity and consistency, but flexible enough to accommodate different types of trials and to allow investigators to highlight what matters most.  

Why do we need your input? 

On paper, this approach has clear advantages. However, we know that changes like this can unfold differently in practice depending on the types of trials you are working on, your role, and your organization. We want to understand the real-world impact before finalizing the proposed form.  

Designing the form effectively would mean less time spent navigating forms and more time focusing on the science – and a clearer, more consistent review process. But success depends on hearing from you.