Through Request for Information (RFI): FDA-NIH Resource on Terminology for Clinical Research, NIH aims to solicit public comments on a joint FDA and NIH initiative to clarify clinical research terms related to innovative clinical study designs, including studies using real-world data (RWD) to generate real-world evidence (RWE).
Specifically, FDA and NIH are requesting comments regarding the clinical research terms included in the glossary. Comments can be submitted electronically through Comment Form: FDA-NIH Resource on Terminology for Clinical Research.
The source material is available at Glossary of Terms and Definitions. To share a few examples:
- Data Lake—a controlled, centralized environment that stores structured and unstructured data in its native form and provides infrastructure for organizing large volumes of diverse data from multiple sources.
- Pragmatic Clinical Trial—a clinical trial designed to efficiently inform decision-making on the benefits, burdens, and risks of health interventions in representative populations by including pragmatic elements that 1) are partially or fully integrated into routine clinical practice and/or 2) that streamline trial design and conduct.
- Target Trial Emulation—a framework for designing and analyzing an observational study based on conceptualizing a target randomized trial to answer a scientific question and designing the observational study to mimic the trial estimand(s) (including specification of population eligibility criteria, treatment strategies and assignment procedures, outcomes, handling of intercurrent events, and follow-up period).
Submitting a Response
The website includes a comment form with specific questions to address. Commenters may provide responses to one or all the topics listed in the comment boxes found on the form. Do not include any proprietary, classified, confidential, or sensitive information in your response.
The deadline for submitting comments is June 24, 2024.
This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the government to provide support for any ideas identified in response to it.
Inquiries
Direct all questions to NIH’s Office of Science Policy at SciencePolicy@mail.nih.gov.