Revealing the Unknown: How the COVID Active Research Experience (CARE) Registry is Enhancing Community Health

An interview with Dr. Nancy Dreyer of IQVIA.

[Dr. Peeples] The CARE Registry was initiated in Spring of 2020, relatively early in the pandemic. What experience and capabilities enabled IQVIA to tackle this enormous initiative with such speed while maintaining the rigor, quality, and usefulness of the registry?

[Dr. Dreyer] This is one of those cases where experience matters. At IQVIA, we have the scientific know-how, the technology, and the unique data assets to conceptualize, design and implement this type of large-scale registry. Let me give you three proof points that demonstrate our foundational capabilities: 

[Dr. Peeples] In the conceptual stage, what were the most important building blocks of the CARE Registry? That is, what were your primary research objectives and what questions were you seeking to answer?

[Dr. Dreyer] Much of the early research conducted on COVID-19 was focused on hospitalized individuals and the important efforts to save lives. We believed there was also much to be learned from non-hospitalized people in the community, some who were getting seriously ill and some who were not. We started with a registry focused on symptom occurrence, severity, and progression or resolution over time. And of course, we took into account people’s underlying health conditions.

In devising the CARE Registry, an essential building block was to look beyond claims-based medical encounters and focus on what people were actually experiencing, as well as their behaviors based on those experiences. We gather symptoms and couple this with self-reported medication use. Importantly, we’ve looked not only at prescription medications but also over-the-counter (OTC) medication use, as well as vitamin and supplement use. There is a great deal of interest in understanding whether these medications can serve as a modifiable factor, if you will, that could help one feel better, faster.

And now, I’m excited to share that we started looking at vaccine users and recipients of the new vaccines to try to see if they are safe and effective and to compare the experience of people who’ve been vaccinated to those who haven’t.

[Dr. Peeples] IQVIA has many other sources of real world data, including claims and electronic medical records. Can these data be linked to the CARE Registry?

[Dr. Dreyer] As a condition of participation, we gain participant permission to link their data with various resources such as outpatient pharmacy prescriptions or medical encounters. IQVIA is rich in its de-identified data assets, and we have access to approximately 90 percent of the outpatient pharmacy prescriptions in the United States. This allows us to understand what people were treated with, in general, and for COVID-19, it allows us to confirm their self-reporting on various outcomes, such as medically-attended events. This linkage process provides a validation or an extension sample that strengthens the reliability and the generalizability of our findings.

[Dr. Peeples] There are numerous other real world evidence and observational research initiatives that are ongoing in COVID-19.  How does the CARE Registry contrast and compare to these other efforts?

[Dr. Dreyer] The CARE Registry complements a lot of other research that is being done, but I believe our registry is unique in several ways.  It provides an early indicator of benefits and risks and early descriptors about patient experience. Other differentiators include our focus on symptoms and symptom severity, reporting directly from the people who are impacted. The record linkage capability also sets this registry apart because it enables a validation of self-reporting. Inclusion of information on OTC medications (e.g., antihistamines, proton-pump inhibitors), vitamins and supplements is unique and will contribute to a better understanding of complementary medicine. And of course, we examine the fast-moving field of vaccines. Our registry is flexible. When questions arise, we can answer them.

[Dr. Peeples] Recently the life sciences and pharmaceutical industry have been embracing collaboration in numerous ways, from research to drug distribution. How is IQVIA collaborating and sharing CARE Registry data with external stakeholders?

[Dr.Dreyer] We take this responsibility very seriously. The first group that we need to give back to are the participants who provide data for CARE. There is no compensation for participation, and we recognize their time commitment. Consumers want to understand the type of symptoms being experienced by others, how long they experience it, and how common certain events are, among others.  The CARE Registry insights can offer some comfort to help them understand that they are not the only one going through this illness or experiencing certain symptoms. In time, we’ll be able to offer even more insights about the duration of those symptoms, such as loss of taste or smell.  As an epidemiologist, I want to be cautious not to mislead, and so I’m highly cognizant that some areas will not be amenable to quick answers.

We continue to improve our platform and reporting so that insights can also be used by other stakeholders, such as regulators, governments and companies that make treatments or vaccines. We currently have an agreement with the US Food & Drug Administration (FDA) for performing agile on-demand analytics. This entails periodic virtual meetings with FDA representatives to hear the questions people are asking them, and we provide insights based on the CARE Registry.  For example, we provided de-identified data related to the use of hydroxychloroquine and COVID-19 symptoms pre- and post-treatment.

[Dr. Peeples] Awareness of racial inequities in health care access and outcomes is receiving more attention, and not a moment too soon. What efforts are being made to equalize access to the CARE Registry across all patients?

[Dr. Dreyer]  Now that we’ve established that we can collect information from people via the internet and they will participate, we’re now focusing on extending our outreach to minority communities. We’re focusing on what will engage them to participate in the registry. And, we will strive to give back to them the insights that will be important to them and their specific population.

[Dr. Peeples] Nancy, can you talk a little bit about how the pharmaceutical industry can avail itself of the data and the learnings from the CARE Registry?

[Dr. Peeples] As researchers, I think that we would all agree that with every research project, we learn something that makes us better for the next project that we take on. What have you learned from deploying the CARE Registry, and how can you use these learnings in your next efforts?

[Dr. Dreyer] I think one of the most enduring lessons I will take away from this work is the enormous value we, collectively, get from listening to consumers and how we can couple this kind of data with systematic evidence generation to really understand the benefit and the risks of treatments and vaccines. We need more than one approach to get answers. The idea that we wait until the ideal clinical trial is done, sometimes several years, before we have an answer is not good enough.  I heard an inspiring talk this summer entitled When Decisions Can’t Wait: A Look at Urgency, and it’s been echoing in my head. It emphasizes why we need this combination of rapid intelligence generation and rapid signal detection, and this combination approach will benefit regulators, pharmaceutical manufacturers and most of all, public health.

[Dr. Peeples] Thank you for your and IQVIA’s important work in contributing to solutions for this pandemic.  I hope that everyone takes time to see how they engage with the CARE Registry. 

To learn more about the CARE Registry:

Visit this website to learn about the registry, how to participate, and to see some of our summarized results: https://www.helpstopcovid19.com/

Visit IQVIA Real-World Solutions to discover innovative ways to generate evidence and engage stakeholders across the entire healthcare ecosystem by clicking this link: https://www.iqvia.com/locations/united-states/solutions/real-world-evidence