Real-world evidence (RWE) is becoming a key part of medical device evaluation, helping to assess how devices perform in real-world settings. However, for RWE to be useful in regulatory decisions, the research methods and data that support it must be rigorous and reliable.

NEST developed the Research Methods and Data Quality Frameworks to provide clear guidance on conducting high-quality RWE studies. Originally released in 2020, these outline best practices for study design, data assessment, and research methodology. Version 2.0 reflects updates based on the latest FDA guidance, findings from NEST Test Cases, and input from regulatory, industry, and academic experts.

Setting the Standard for Reliable, Actionable RWE

As RWE plays a larger role in medical device evaluation, ensuring consistency and credibility in how real-world data (RWD) is collected and analyzed is critical. These updated frameworks provide structured guidance to researchers, industry professionals, and regulatory stakeholders, helping to improve the quality and reliability of RWE.

The Research Methods Framework defines and informs study design, including how to outline disease and device parameters, select patient populations, and determine appropriate study outcomes. It establishes key principles to support well-designed RWE studies that generate relevant and reliable results.

The Data Quality Framework addresses key challenges in working with RWD, particularly electronic health records (EHRs). Manufacturers face ongoing hurdles in ensuring that data are consistent, complete, and fit for a specific study question. This framework provides guidance on improving data governance, curation, and assessment while also helping organizations enhance their data quality practices.

What’s New in Version 2.0?

These frameworks have been updated to align with evolving industry needs and regulatory expectations. Key refinements include:

• Improved study design guidance to strengthen methodological rigor and reflect lessons learned from NEST Test Cases.
• More detailed data quality benchmarks to help organizations assess the reliability, completeness, and relevance of RWD.
• Additional guidance on applying RWE in regulatory and clinical decision-making to support the effective use of RWD.
• A structured approach to RWE generation to ensure transparency, consistency, and reproducibility in regulatory submissions.

Your Expertise is Needed

NEST encourages feedback from researchers, industry professionals, regulatory experts, clinicians, data scientists, and others involved in RWE generation and evaluation. Whether you work directly with RWD or apply it in decision-making, your insights will inform refinements to maintain the Frameworks’ practicality and rigor.

How to Participate

Public Comment Period: February 28, 2025 – April 29, 2025
Submission Deadline: 5:00 p.m. ET, April 29, 2025
Submit Your Comments: Open Call

This is an opportunity to contribute to the development of RWE by ensuring the frameworks remain valuable for regulatory-grade research. If you have experience with RWE methods or data quality, your input can help improve how real-world data is used in medical device evaluation.

For more information, contact nestcc@mdic.org.