Collecting Research-Grade Real-World Data
Zulema Cardet, Sr. Consultant, Biopharma Services
Since 2016, the FDA has placed increased focus on the analysis of real-world data (RWD) to support regulatory decision-making. As a result, pharma struggles to collect research-grade information from static sources such as physician charts and medical billing.
Recognizing this gap, Cardinal Health’s Real-World Evidence and Insights team created new strategies for collecting prospective and retrospective RWD with two types of customized research networks.
In 2018, the GPO-agnostic Oncology Provider Extended Network (OPEN) launched with the ability to identify patient populations, study multiple tumor types, and allow researchers to question physicians. The network sets new standards for market and comparative effectiveness research and historical control arms.
In 2020, Practice Research Networks (PRN) were launched to create non-interventional research agreements with practices, who complete case report forms, recruit patients for studies, or provide disease progression, imaging, genetics, patient-reported outcomes, quality of life, and pathology data. Because it allows for prospective patient enrollment, researchers employ the same rigorous inclusion and exclusion criteria as a clinical trial.
Because neither network is limited to structured EMR data, both can identify and engage rare patient populations, providing complete data with multiple collection methods, manual chart review, and the ability to recruit new providers.
The physician-led approach of OPEN has resulted in over 35,000 chart reviews while PRN has grown quickly with 26 practices signing on in less than 20 months, and as it develops, it will be used to conduct interventional research, including pragmatic and decentralized clinical trials.