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2026
Here’s What We Heard About the Proposed Clinical Trial Specific Application Form, and What’s Next
Earlier this year, we asked the research community to weigh in on a proposed Clinical Trial Specific Application Form that would consolidate clinical trial information currently provided across two application components into a single, semi-structured form with page limits (NOT-OD-26-058). On behalf of the NIH Clinical Trials Application Working Group, I am pleased to share what we heard, and how your feedback will help shape our next steps.
FY25 Inclusion Data for NIH-Supported Clinical Research Now Available by NIH Spending Category
In May, we shared NIH-wide fiscal year (FY) 2025 enrollment data on the sex, race, ethnicity, and age of participants in NIH-supported clinical research, offering a broad view of inclusion across the NIH portfolio. More detailed FY25 enrollment data are now available through the NIH Research, Condition, and Disease Categorization (RCDC) Inclusion Statistics Report.
What Study Information Should Be Included on a ClinicalTrials.gov Entry?
A ClinicalTrials.gov study record is intended to summarize key information from a study’s protocol and the study’s findings. The study sponsor or investigator is responsible for ensuring that their studies follow all applicable laws and regulations and for submitting complete, accurate, and up-to-date information about their study.
FY25 Enrollment Data from NIH-Supported Clinical Research Now Available
As part of NIH’s continued efforts to increase the transparency of the NIH research portfolio, data on the sex, race, ethnicity, and age of participants in fiscal year (FY) 2025 NIH-supported clinical research are now available.
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 for investigator-initiated clinical trials.
Does Good Clinical Practice (GCP) Training Consistent with the International Conference on Harmonisation (ICH) E6 (R3) Meet the NIH Requirement?
Yes. GCP training consistent with ICH E6 (R3) meets the requirement stated in the NIH Grants Policy Statement (GPS).
Feedback Sought on NIH Draft Resources to Support Participants in Implantable Device Trials
We seek your input on two resources aimed at supporting participants in NIH-funded implantable device clinical trials. Comments on this Request for Information are voluntary and should be submitted electronically until May 25, 2026.
Planning an NIH Application involving Basic Experimental Studies with Humans (BESH)?
NIH announced that Basic Experimental Studies with Humans (BESH) will no longer be considered clinical trials by the NIH.