AZ Q&A: Real-world evidence studies

AstraZeneca announced a new partnership last week with HealthCore, the health outcomes research subsidiary of WellPoint, to conduct real-world evidence studies designed to determine how to most effectively and economically treat diseases.

In the days since the announcement, we’ve received quite a few questions about the collaboration: how it will work, what we will study, and how it will benefit AstraZeneca, the health care system and – most importantly – patients.

Dr. James W. Blasetto, AstraZeneca’s vice president of U.S. strategic development, joins us to answer some of those questions:

What are real-world evidence studies?

These studies examine how existing medicines and treatments are working in the health care system. Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, insurance claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess how various treatments impact how long patients stay in the hospital, whether they are readmitted to the hospital, a patient’s overall health status, cost of care and other key evidence-based outcomes.

What will AstraZeneca’s work with HealthCore include?

The research will include observational studies that look both ahead and back on disease treatments, as well as comparative effectiveness research. It will analyze how medicines and treatments already on the market are working in a number of disease areas, with a special emphasis on chronic illnesses. It also will provide insight into the types of new therapies most needed for treating and preventing disease.

How will the research help look at potential new therapies?

The volume of data available from this partnership will provide powerful insights that can help inform discovery and development of new medicines by helping us better understand what unmet patient needs exist – and how we can help meet those needs. It also will help us gain a better understanding of the impact of our medications on the overall cost and quality of treating diseases.

What is the difference between clinical trials and real-world evidence studies?

While randomized, controlled clinical trials are the gold standard by which safety and efficacy of drugs are demonstrated in the United States, these studies often are designed with numerous controls that may limit the ability to answer questions related to the real-world delivery of healthcare.  Studying the use of a drug in a real-world setting can provide new insights into costs, optimum co-therapies, and medical best practices that are not available through clinical trials.

Why is AstraZeneca getting involved in this kind of research?

Everyone in the health care system is feeling economic pressure and is looking for ways to assess cost and clinical effectiveness of treatments. Advances in health information technology, including the availability of deeper patient-level data, create the opportunity to conduct meaningful real-world analyses that identify both the effectiveness of existing treatments and areas of unmet patient needs.

Are there privacy issues associated with this type of data?

Health information provided to AstraZeneca from HealthCore is stripped of personal identifiers, such as name and address, before it is used for research.  Individual health information is private and we take great care in protecting it. WellPoint and HealthCore are legally required to protect patients’ health information by federal privacy regulations, such as the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act. The arrangements between HealthCore and AstraZeneca are structured to protect patients’ health information.

Note: Here is the Wall Street Journal Health Blog post on the agreement.

– By Tony Jewell