Funding Opportunity Announced for Generating Real-World Evidence in Regulatory Decision-Making
The FDA protects the public health by ensuring enhanced drug development and safety in the United States. It encourages innovative methods to produce scientific evidence in accordance with regulatory submissions and facilitates the development of new study designs, data sources, methodologies, and technologies. One of the FDA’s primary enforcements is implementing scientific data supporting marketing approvals that meet high evidentiary standards.
As a part of the agency’s 21st Century Cures Act, the FDA is dedicated to exploring and incorporating the use of real-world data (RWD) and real-world evidence (RWE) to achieve the successful monitoring of both approved drug safety and the approval of new or post-approval study requirements for already approved drugs. As such, the FDA has published an RWE framework and guidance documents to aid a multifaceted RWE Program focused on evaluating the regulatory use of RWD and RWE.
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According to the official FDA notice, “the Framework highlights the need to explore the use of tools to improve accessibility, connectivity, organi(s)ation, and analyses of RWD.” Moreover, “the agency expects that drug sponsors, health care providers, patients, and the public at large will have a better understanding of how RWD and RWE can be utili(s)ed in the regulatory process.”
In support of the guidelines and framework, the FDA has released a funding opportunity announcement to address the gaps in knowledge currently limiting the usefulness of RWE and RWD. The primary objectives of the opportunity are as follows: “a) improve the quality and/or use of RWD, b) promote better understanding of RWE study designs, and c) develop specific tools to evaluate aspects of RWE generation.”
The FDA outline the scope of the funding program to include:
- Designing and conducting demonstration projects that promote clarity and better understanding of key components of studies utili(s)ing RWD
- Identifying innovative approaches to interventional studies (clinical trials) that incorporate RWD to generate RWE
- Identifying innovative approaches to non-interventional (observational) studies that incorporate RWD to generate RWE
- Evaluating feasibility of RWD to capture disease-progression endpoints or disease-control endpoints, especially for therapeutic areas for which RWD has not been used extensively
- Addressing challenges involving data curation, transformation, and analysis in studies using RWD
- Demonstrating how registries can add value, including linking of registries to other RWD sources
- Using RWD/RWE to enhance patient diversity in clinical research, including for historically under-represented populations
- Promoting the use of innovative technologies, such as digital health tools, predictive algorithms, and sensors
The funding opportunity was launched in December 2022 and will close in late February 2023.
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