Managing Real-World Patient Data Can Improve Trial Design

Properly identified and managed, real-world data (RWD) can streamline trial design and improve execution to save time and money, says Michel Denarie, a senior principal with IQVIA’s Strategic Drug Development team, a group that helps sponsors with their early clinical development strategy.

Patient data represent an overlooked source of valuable information, Denarie says. “Clinical trial development has been mostly done looking at the expertise of physicians, toxicologists, [and] regulatory experts, which is still extremely important,” he notes. However, giving equal attention to patient data can help identify better patient markets and locations, and narrow down the search population, according to Denarie.

In many instances, a local “culture doesn’t have enough money to go after every indication possible,” Denarie says. Those searching for the best trial location tend to rely on publicly available literature or incident reports, but those are often based on very small, dated samples.


Free for ACRP Members – Denarie will present a Webinar on October 3 entitled “How Can Real World Data Improve the Early Clinical Development Process?” This Webinar will review in detail the types of Real World Data sources available in the US, Europe and Asia, both proprietary and government-sourced, that can be leveraged to inform trial design and execution. View Webinar Details

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Instead, Denarie advocates using longitudinal prescription claim data or electronic medical record (EMR) data to get a much better picture of “the addressable population.” With that in hand, “you can apply some of the major inclusion/exclusion criteria and see at the end of the funnel how many people you have left,” he explains. “This can offer an accurate estimate of the likely available patient population for the trial.”

Patient data can also be used to determine the best countries to consider at the earliest stages of trial planning. While the United States remains the most popular trial destination, Denarie notes, others such as China, Ukraine, Poland, and Russia have emerged as viable options.

One key is being able to identify and tap into the various types of RWD available in each nation. Some of it is proprietary, but much of it is government-sourced. Many nations are catching up to the U.S. in terms of data quality and accessibility, Denarie adds. However, regulatory bodies in different countries are all over the spectrum in terms of accepting RWD as evidence in clinical trials.

Author: Michael Causey