FDA Seeks Access to IQVIA Community Registry: How is COVID-19 Impacting People & What are they Doing About It?

FDA Seeks Access to IQVIA Community Registry How is COVID-19 Impacting People & What are they Doing About It

IQVIA, a large contract research organization and provider of various analytics and information services to the life sciences has partnered with the U.S. Food and Drug Administration to provide agile analytics from the IQVIA CARE Project COVID-19 registry to support better understanding of how people in the community are impacted by exposure to SARS-CoV-2, the virus behind COVID-19. This accumulating registry reveals differing symptoms associated with COVID-19 as well as whether any medications or vitamin supplements individuals are consuming impact the severity of the COVID-19.

TrialSite provides a brief breakdown of this announcement.

What is the CARE Project?

A patient registry  targeting those with COVID-19, it’s open to U.S.-based residents who believe they may have been exposed to SARS-CoV-2, whether they were diagnosed with COVID-19 or not. This community registry study was initiated to advance understanding of COVID-19 as experienced in community settings.

Whose leading the effort?

Nancy Dreyer, chief scientific officer for Real World Solutions

What’s the Goal?

The primary goal is to better understand how COVID-19 is affecting people in the community setting and to determine if various preventive treatments are offering any relief. Such treatments include not only medications but also vitamin supplements.

Nancy Dreyer, IQVIA’s chief scientific officer for Real World Solutions, said that, “While there has been so much focus on treatments for hospitalized cases of COVID-19, little is known about the symptoms experienced by most people in the community and what factors, if any, explain why some people do not get seriously ill. This project allows us to look at the possible roles of both prescription and nonprescription drugs, as well as nutraceuticals, such as vitamin D, zinc and herbals.”

When was it launched ?

April 2020

What are participants required to do?

They sign on to the study website and periodically contribute information to help create a clearer picture about how people are responding to infection with COVID-19. The individual responses are kept confidential, however aggregate responses are analyzed for insights.

How many people have thus far signed up?

Over 20,000 in all 50 states.

What will the FDA & IQVIA partnership focus on?

The pair will leverage the ongoing CARE Project to offer rapid insights into important COVID-19 questions that have yet to be explored or answered well via other available real-time data. Registry study lead Dreyer reports, “These data will give us unique access into symptoms experienced in community settings and the potential role of various preventive agents, and the agile analytics process offers us a quick way to get reliable insights.”

What technology or product solutions power the registry?

The registry is made possible by IQVIA CORE™, an analytical platform leveraging IQVIA’s healthcare expertise, data analytics and technology to help integrate human science expertise with advances in data science and technology to make better decisions that will advance human health.

Relevant to IQVIA CORE, in 2019 the Life Science Strategy Group named IQVIA the leader in real world and real world evidence services.

What is IQVIA CORE?

According to the company’s website to leverage technology, data and analytics for clinical development. Its an innovative proprietary way to integrate unparalleled data, transformative technology and advanced analytics as well as domain expertise to power solutions to help their clients be more successful. Actually, a consultative offering packaged and sold to biopharmaceutical clients, the solution has been applied primarily to clinical development to date.

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies Human Data Science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With approximately 67,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

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