The growth of Real-World Evidence (RWE) from sources including patient registries, claims data, electronic medical records, digital health technologies and more has powered the ability of Medical Affairs to drive patient outcomes. Here, the MAPS Executive Consortium describes how.
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 Since the Cures Act, FDA has issued multiple guidances and draft guidance statements regarding use of RWE for regulatory applications.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?
At the MAPS 2022 Global Annual Meeting, we sat down with Riad Dirani, Vice President of Global Health Economics and Outcomes Research at Teva Pharmaceuticals, and Omar Dabbous, Vice President of Global Health Economics and Outcomes Research and Real World Evidence at AveXis to chat about the structure and activities of HEOR within Medical Affairs.
This white paper provides Medical Affairs professionals with the background and history of Real-World Evidence, and its applications in the biopharma industry to benefit patients.
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.
In this episode of Partnering for Today and Tomorrow we discuss the functions and activities of key internal partners and how we identify potential areas for compliant collaboration by MSLs with key internal partners.
The objective of this podcast is to discuss how the 21st Century Cures Act has led to new initiatives at FDA involving Real World Evidence.
• Define health economics and outcomes research (HEOR) and its relationship to Medical Affairs
• Understand HEOR professional competencies included in the ISPOR Competency Framework, and which are most relevant to Medical Affairs professionals
• Discuss potential applications of the competencies by different stakeholders (employers, new professionals, students, academia)
• Identify ways for Medical Affairs professionals to further their HEOR knowledge and skills