RWE 101 – Evolution of Regulatory Affairs

Real-world evidence (RWE) and real-world data (RWD) are increasingly influencing regulatory affairs in the biopharmaceutical and healthcare industry. This change has been brought about due to the recognition of the value of real-world data in assessing the safety, efficacy, and effectiveness of therapies beyond traditional clinical trials.
[1] Increased Importance of Post-Marketing Surveillance: With RWE, regulatory agencies now have increased access to post-marketing surveillance data. This data is helping in better identification of adverse events and monitoring the safety of products in the market.
[2] Regulatory Decision Making: RWE is becoming increasingly significant in regulatory decision-making, including label extensions, post-approval studies requirements, and in some cases, approval decisions themselves. Regulatory bodies such as the FDA and EMA are now considering RWE as part of their evidence package, though with caution and scrutiny.
[3] Guidelines and Policies: Regulatory bodies are developing guidelines for the use of RWE in regulatory decision-making. The FDA, for instance, has issued guidance on the use of RWE to support approval of new indications for already approved drugs or to satisfy post-approval study requirements.
[4] Innovative Trial Design: The increased use of RWE is promoting the use of innovative clinical trial designs like pragmatic clinical trials (PCTs), which make use of real-world data.
[5] Technology and Data Privacy Considerations: With RWE coming largely from electronic health records, insurance claims data, and wearables, regulatory affairs, especially study start-up professionals, will need to grapple with data privacy and cybersecurity issues. There’s an increasing need for regulations that guide the use and protection of such data.
[6] International Harmonization: As RWE can be collected globally, there are efforts to harmonize the guidelines across different countries to make multinational studies feasible.
[7] Transparency and Trust: Ensuring the validity and reliability of RWE studies is a growing concern. This has led to an increased focus on transparency in data collection, analysis methods, and reporting, all of which regulatory affairs must oversee, especially in the context pf RWE used for regulatory submissions, such as marketing authorisations..
Thus, the intersection of RWE and regulatory affairs is evolving and holds potential for improving healthcare decisions and outcomes. Regulatory affairs professionals must adapt to these changes, requiring new skills and competencies in data analysis and understanding of the evolving regulatory landscape for RWE.

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