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Real World Data Clinical Design Operations

Our goal is to unleash the value of Real-World Data in the era of Artificial Intelligence through rigorous analysis and strategic partnerships.

Real-World Data in Clinical Design and Operations

At Janssen R&D, we’re harnessing the power of diverse and rich real-world data spanning from omics, electronic health records (EHR), claims, imaging, lab, wearable, consumer data and more and advanced techniques such as Artificial Intelligence/Machine Learning (AI/ML) to derive insights on novel disease targets, patient journey, real-word endpoints, external control arms, AI-augmented patient finding and matching to enhance our clinical trials, and more.

One example of our use of real-world data is in the area of developing external control arms. In 2019, we received expedited approval for an innovative medicine for the treatment of a specific cancer with limited options for patients.

The U.S. Food and Drug Administration (FDA) approval relied on our use of real-world data as an external comparator arm which demonstrated clear, enhanced efficacy versus the evolving standard of care. Building upon this success, we are scaling the use of external control arms across the therapeutic areas to develop bespoke real-world data sets to serve as external control arms to enhance our evidence package for both regulatory and access purposes.

With this information at our fingertips, we provide scientists, doctors, and patients the ability to make decisions that are based on novel insights derived from a deep understanding of data. Through strategic partnerships and rigorous analysis, we are leveraging the most comprehensive data sets to ensure we understand and can help patients of all backgrounds.

In another example, real-world data was used to identify novel risk factors associated with a patient’s chances of developing an infection by invasive E. Coli. These risk factors were then incorporated into the clinical trial protocol to inform patient enrollment and accelerate the time to study completion.

Real-world data is being leveraged every day for a variety of other use cases aimed at developing novel insights and conducting more efficient clinical trials. Our scientists are leveraging this data to assist as they develop and validate novel clinical endpoints, discover new disease biomarkers, identify optimal sites for clinical trials, and accelerate recruitment of patients into our studies.