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). The goal is to reduce redundancy and burden, clarify expectations for applicants, and make critical information easier for reviewers to find. 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.

Who We Heard From
Of 96 total responses received, NIH reviewed 87 from the extramural community. Six duplicate responses and one that did not address the request for information (RFI) were excluded from review, while two responses from NIH staff were considered separately, along with other internal feedback. An unedited list of the responses is available as a downloadable file. 

• 72 individuals responded for themselves, 10 on behalf of an organization, and five did not specify
• Respondents included clinical trials researchers, grant reviewers, human subjects protections officials, organizational officials, and others  
• Most held multiple roles, particularly clinical trials researchers and grant reviewers
• The vast majority were from academic research institutions
• Feedback was generally consistent across groups. Where meaningful group differences emerged, they are described separately.

What We Heard
Key themes focused on anticipated burden, the structure of the form itself, and its applicability across different clinical trial types.  

Could a Streamlined Approach Reduce Burden?
Among respondents who weighed in on burden, nearly two-thirds (63%) expected the proposed form to reduce the effort needed to prepare an application. Another 19% expected little or no change, while 19% anticipated an increase. 

Most respondents anticipated neutral to positive overall impacts on researchers, reviewers, and grants administration workflows, with the review process receiving the highest positive assessments. Respondents pointed to less duplication, clearer organization, and a more focused application.

At the same time, organizational officials pointed to the practical consideration that a new form can require substantial transition time and effort to implement. Any changes should consider the impact on updating institutional workflows, adapting electronic systems and automated validations, and downstream ClinicalTrials.gov processes.

Respondents also were clear that reducing burden would depend on getting the details right, particularly in the form’s structure, page limits, and instructions.

What Matters Most for a Streamlined Form
Respondents generally welcomed a streamlined application, but they also identified areas where the proposed form may need refinement.

Page limits were a recurring concern, particularly for complex study designs and methods, statistical analyses, feasibility, and human subjects protections. These concerns become more significant when providing enough detail about the Research Plan and trial methods could leave less space for significance, innovation, rationale, and other review considerations. Some respondents also questioned whether dividing information into structured sections could make it harder to present and review a study as a coherent whole.  

Some noted potential overlap among sections, and those involved in human subjects protections emphasized that information about risks, consent, safety monitoring, and protections needs to be easy to locate.

Respondents identified information they considered important to review that was not readily apparent in the proposed form. Some respondents encouraged alignment with existing standards and reporting requirements, so the application does not inadvertently disrupt information needed for other research oversight and reporting processes. Considerations centered around community and patient engagement, multisite organization and site readiness, statistical analysis details, recruitment and retention, intervention-specific information, and clearer treatment of inclusion requirements.

Across these comments, respondents wanted clear instructions about where information belongs, how much detail NIH expects, and how information collected elsewhere in the application would fit with the new form. Examples and templates were among the suggestions for making expectations easier to understand. 

Would the Proposed Form Accommodate a Range of Clinical Trials?  
Views were mixed. Among respondents who commented on applicability, 30% thought the proposed form would be broadly applicable across clinical trials designs, while 27% saw its applicability as more limited. The largest group (43%) said that its applicability was unclear. Respondents felt that the proposed form would fit more readily with traditional trials, but they questioned its applicability to other trial types, including complex or evolving trial designs, behavioral and psychosocial research, early stage studies, and several other types. Several respondents suggested that design-specific instructions, flexibility to indicate when sections are not applicable, or other tailored guidance could help address these differences.

What’s Next
Feedback to the RFI has proven to be encouraging and helpful as we move forward with developing a streamlined form, while also identifying areas that warrant further consideration regarding how information is collected in NIH applications. 

At present, NIH is modifying the proposed streamlined application form to address feedback we received. We also are determining how to incorporate this new model for clinical trials applications into the broader, multifaceted application process. As the next generation of application forms is developed, this new approach to clinical trials applications will be included. The key challenge is to fit this new approach into an overall structure for human subjects’ research (including studies that are not clinical trials) and the overall NIH research application process.

Stay tuned as we will share updates as decisions are made, templates generated, guidance provided, and additional resources created as implementation progresses.