The Real-World Evidence Alliance is a coalition of real world data (RWD) and analytics organizations with a common interest in harnessing the power of real world evidence (RWE) to inform regulatory decision making to improve patients’ lives.

This blog is a conversation between IQVIA’s representatives for the RWE Alliance -- Jennifer Christian, VP of Clinical Evidence and Epidemiology, and Marni Hall, VP of Clinical Evidence, Head U.S. Regulatory Science and Strategy. IQVIA’s role in the Alliance, as a founding member, is to develop and align on key principles and policies that advocate for advancing the use of RWE in regulatory decision making.

Q: Can you each share a little bit more on your regulatory background and experience?

Marni Hall (MH): Prior to joining IQVIA, I worked as Director of Regulatory Science in the Office of Surveillance and Epidemiology (OSE) at the Center for Drug Evaluation and Research (CDER) at the FDA. Part of that role involved programs to evaluate new data methods and tools for use in regulatory reviews, an essential step to modernize how regulated medical products are brought to market.

At IQVIA, I focus on advancing the use of real world evidence for regulatory decision making, a type of regulatory science. This includes pilot projects that explore fit-for-purpose use of real world data for evidence generation, and regulatory strategies for specific submissions that include real world evidence.

Jennifer Christian (JC): My regulatory engagements have either been through supporting product approvals and label expansions with the use of RWE or through larger scientific collaborations, such as with Friends of Cancer Research, National Academy of Medicine, or Duke Margolis RWE Methodology Group, where the work has aimed at advancing the use of RWE for regulatory decision making.

Prior to joining IQVIA, I worked for a large pharma company where my experience was in directly supporting products for regulatory approval and post-approval evaluations, as well as larger scientific engagements around evidentiary requirements for using RWE to support regulatory decisions.

Q: What motivates you when it comes to the regulatory use of real world data (RWD) and RWE?

JC: We see an important role for RWE, one that’s complementary to clinical trials. It will allow us to expand our knowledge on the clinical effectiveness and safety of treatments, devices, and vaccines in larger real-world populations and care settings.

MH: Regulatory use of RWE holds the opportunity to inform the evaluation and monitoring of medical products with additional data not captured by traditional clinical trials. Utilizing RWD enables us to learn more, even faster, and expand our understanding of the benefit/risk profile of a product. The goal is improved patient outcomes.

Q: What sparked the Real-World Evidence Alliance to come into existence?

JC: There have been specific efforts that have brought a broad set of stakeholders together to advance RWE, but we realized that there wasn’t an organized way amongst real world data and analytics organizations to share experiences and best practices for submitting RWD and RWE to regulators. We felt like there was an opportunity and a need to form an Alliance (and potential for a trade organization considering increased interest), especially given the upcoming RWE guidance to be released later this year.

MH: Regulatory frameworks for use of RWE are rapidly evolving. Some of that has been in response to 21st Century Cures Act and legislative mandates, but it’s also in response to the pandemic. The formation of the Alliance indicates a maturation of expanded use of RWE, and that it is now appropriate to have experienced organizations formally help shape how it is used.

By having a group that’s solely focused on RWE, member organizations can bring our collective experiences, objectives, and perspectives from working on RWE-related projects to the table and have a seat to more directly inform how the regulatory landscape evolves.

Q: As it stands today, what are the key principles and policy goals for the Alliance?

JC: The four key principles that the member organizations have aligned on are to

1. Advance the FDA’s RWE framework.
2. Support the use of RWE as a tool to better understand treatment effects in underrepresented populations.
3. Enhance opportunities for RWE organizations to consult with the FDA.
4. Increase communication on the generation and use of RWE.

These principles, that are visible on our website (RWEAlliance.org), will guide our activities and advocacy. We’re currently working on a set of activities and related policies underneath each principle.

Right now, we’re focused on introducing ourselves to our stakeholders, developing the set of priorities to tackle this year, and formalizing our membership structure going forward. Over the coming year, you’ll see a lot more in terms of exact policies that the Alliance is committed to addressing.

MH: We’re also working on how the Alliance may expand, and/or engage additional organizations that are interested in joining. We’ve intentionally started with a focused set of principles and a small group so we can move quickly to have an impact on upcoming policies.

JC: It's been very encouraging to see the response to the Alliance so far, particularly among FDA leadership and individuals on the Hill; we get the sense that we are filling an unmet need by establishing this coalition.

Q: What do you hope the Alliance helps achieve for IQVIA’s customers and for the industry at large?

MH: By coming together as a group of organizations with one voice, by seeking a seat at the table, and by engaging with policy stakeholders, we aim to contribute to how the regulatory landscape for RWE evolves. It is a learning process for all of us, and the Alliance provides the opportunity to add our collective expertise to the process.

JC: Agreed. In addition to achieving more clarity and communication around RWE policies as they evolve, we hope to inform and shape the process for submissions, including audits, documentation, and standards surrounding when RWE is used in a regulatory submission.

Q: IQVIA launched Connected Intelligence™ earlier this year. How does being a founding member of the Alliance exemplify Connected Intelligence?

MH: IQVIA interacts with organizations in many ways that advance the use of RWE and regulatory decision making in one-off situations. The Alliance is intentionally and proactively leveraging our experience to advance and connect what we’ve been doing in those one-offs to activities in the regulatory lifecycle where RWE could be complementary.

JC: Connected Intelligence is fundamental to the Alliance because we are considering all of the critical factors for leveraging RWE, including analytics, data, technology, and experts to reduce the ambiguity around analyzing and using real world evidence for regulatory decision making.

MH and JC: As representatives of IQVIA, we can carry information back and forth. Just as our experiences within IQVIA provide valuable information to the Alliance and to the FDA, we can also take insights from the Alliance and disseminate them within IQVIA, inform our clients, and bring the thought leadership of the Alliance to our internal activities.