Introduction
The FDA and the NIH have jointly issued a Request for Information (RFI) to clarify clinical research terms related to innovative clinical study designs, including those utilizing real-world data (RWD) to generate real-world evidence (RWE).
Efficient and well-designed clinical research is of mutual interest to both agencies. Recent advancements in science, technology, and innovative research methodologies have opened doors to enhanced clinical research opportunities. These advancements facilitate product development and support using RWE for marketing authorizations, fulfilling post-approval study requirements, and enhancing participant engagement in clinical trials.
Challenges in Terminology Consistency
However, there needs to be more consistent usage of specific terms across the clinical research ecosystem. In response, the FDA and NIH have convened a working group to develop clear definitions for 37 such terms, aiming to establish a common vocabulary within the clinical research community. The goal is to improve communication and understanding within the research community, enabling better evaluation of study strengths and weaknesses and a more straightforward conveyance of innovative aspects of clinical research.
Seeking Public Input
Public input is crucial in shaping future policies and initiatives in clinical research. Visit the official announcement to view the complete RFI and to access the electronic comment submission form. Comments will be accepted through June 24, 2024. The RFI emphasizes that responses should not contain proprietary, classified, confidential, or sensitive information.
If you’re interested in providing feedback and contributing to standardizing clinical research terminology, now’s your chance to make your voice heard.
