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Product Developers are using Real-World Evidence (RWE) for regulatory purposes in an expanding range of contexts. Drug sponsors are directly using RWE as an external control arm in clinical trials. Companies also use RWE to obtain label expansions and to satisfy post-market approval requirements. RWE is also being used to help design traditional clinical studies, to help select clinical trial sites and identify study endpoints. This presentation looks at different regulatory contexts in which product developers are using RWE.
It is hard to overstate the expansion of Real-World Evidence (RWE) over the last 5 years. ISPOR has designated RWE the #1 trend in Health Economics for 2022-2023. Most new drug and biologics applications to FDA now include RWE information.
The use of RWE to support product label expansion has been a primary driver of interest in RWE. The 21st Century America Cures Act, enacted in 2016, required FDA to evaluate RWE in support of new drug indications. Since the Cures Act, FDA has issued multiple guidances and draft guidance statements regarding use of RWE for regulatory applications. The Agency has also utilized RWE in approving expanded indications for drug products. As FDA states at the top of its RWE web page, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”
This virtual presentation will focus on 3 aspects of RWE:
1) What are RWE and Real-World Data (RWD), and how are they different?
2) What are relevant legal and regulatory considerations associated with using RWE for product label expansion?
3) How have applicants successfully used RWE to obtain approval for new drug and medical device indications?
The use and acceptance of real-world evidence (RWE) in the pharmaceutical and biotechnology industries has increased dramatically in the last 5 years. Approximately 70% of new drug and biologic regulatory submissions to the U.S Food and Drug Administration (FDA) now include RWE.1 Nearly 95% of pharmaceutical industry respondents, in a recent survey by Deloitte, expect RWE to play an important role in their companies by 2022.2 Medical Affairs (MA) professionals are in a unique position to champion the use of RWE internally and communicate its value both internally and externally. This white paper focuses on providing MA professionals with the background and history of RWE, and its potential applications in the biopharma industry, so that they may incorporate this knowledge into their areas of functional expertise, and ultimately, benefit patients and consumers in their healthcare decision-making.
This podcast focuses on applications of Real World Evidence including FDA criteria for accepting RWE, types of data, RWE study designs and the Totality of Evidence approach.
There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for applications including regulatory decisions, health technology assessment (HTA), pharmacovigilance and more. However, Asia currently lacks a framework to effectively collect and utilize a broad range of RWD/RWE.
This MAPS podcast details potential areas for compliant collaboration by MSLs with Patient Advocacy Groups.
This session will provide a learning opportunity for our audience by:
When quantitative and qualitative Field Medical KPIs and metrics are aligned with the organization’s strategic plan, these measurements demonstrate value. Defining and communicating this value is an essential task as Field Medical solidifies its role as a strategic pillar within the organization.
This paper discusses the sources and uses of non-registrational evidence and describes why Medical Affairs is positioned to lead and own the nRE Strategic Plan.
This session will provide a learning opportunity for our audience by providing background on FDA’s Offices of Minority Health and Health Equity, and Women’s Health:
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.