As real-world evidence is increasingly used to inform healthcare decision making, including regulatory decisions, robust methodology is becoming ever more critical.

Machine learning combines advanced statistical methods with the results from validation studies to construct new case-identifying algorithms. We have found these methods to offer marked improvement in the accuracy with which we can identify patients of interest. These methods not only reduce bias from misclassification, which translates into more valid research, but we have also been able to identify patients with conditions for which there are no diagnosis codes in claims, such as cancer stage or biomarker status.

Dr. Patti Peeples, CEO of HealthEconomics.Com, sat down with Flora Sandra Siami, MPH, Vice President of Clinical Research, Regulatory Affairs, and Quality Assurance at HealthCore.

The best-designed clinical trial is only as good as the subjects it enrolls…and retains. Recognizing this fundamental truth led our team to create in-house expertise in subject recruitment and retention, and to build a digital solutions resource center to sup¬port these efforts.

Research data can come in all degrees of “cleanliness.” Clean data are free of errors, out-of-range values, missing values, or misplaced values. It turns out that much can be done to improve the “cleanliness” of data — and our Resource Operations team is at the forefront of such efforts.

HealthCore looks forward to the potential, positive impact that real-world evidence may have on regulatory decision making and therapeutics development within the U.S.

We believe pragmatic trials will be a large part of the future of outcomes research – to understanding life science products in real-world settings, evaluating comparative effectiveness and helping to improve patient care.

Pragmatic clinical trials provide the optimal environment to address a broad spectrum of real-world issues, and generate evidence synergistic and complementary to RCTs. For clinicians, pragmatic trials generate evidence that enables better-informed decision making.

Traditional methods of generating evidence, from single data sources and perspectives, often no longer meet the needs of our complex health system. HealthCore has the data assets and expertise necessary for going broad and deep in real-world evidence generation.

As these various efforts to address the growing problem of prescription drug abuse and misuse play out, it will be important to monitor the degree to which they succeed in the real world. Safety and Epidemiology research is providing insights into the effectiveness of these efforts.