How Johnson & Johnson Uses Real-World Evidence to Accelerate Clinical Research

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Key Takeaways:

• Johnson & Johnson (J&J) accelerates medical innovation by leveraging real-world data (RWD) and real-world evidence (RWE) to improve study design, optimize clinical trials and speed regulatory approvals for medical technology ("medtech") products.
• Tokenized RWD enables compliant patient-level linkage across otherwise siloed databases, which will help lead to more reliable and fit-for-purpose RWD to assess and improve upon the safety and effectiveness of medical devices.
• With the scale and breadth of the Premier Healthcare Database (PHD), J&J gains insights into treatment patterns, patient comorbidities and outcomes, turning high-quality data into actionable RWE that supports more precise, patient-centered care.

When Stephen Johnston, Senior Director, Real-World Data Analytics and Research at Johnson and Johnson (J&J), first entered clinical research two decades ago, the landscape was far different. But even then, one thing was clear: Datasits at the core of progress in generating RWE.

Medical device development has always been a race against time. With the pressure to innovate quickly yet safely and to meet ever-growing regulatory demands, the path to approval can be timely and costly. For the drug and biotechnology company (based on 2026 data), J&J, real-world data (RWD) and real-world evidence (RWE) - defined as the critical insights derived from RWD - have become key assets in helping accelerate this process.

"[RWD and RWE] are critical factors in the future of regulatory approvals for medtech," said Johnston during a recent BioPharma Dive webinar.

With a mission to improve healthcare through precision and innovation, J&J focuses on treating medical challenges with smarter, less invasive and more personalized solutions. The company's medtech expertise enables them to target the most difficult-to-reach areas of the body, delivering care across the continuum of surgical specialties. Through strategic partnerships using data platforms such as the Premier Healthcare Database (PHD), the New Jersey-based company integrates RWD and RWE into their research and development processes to help improve the design and efficiency of clinical trials and accelerate time-to-market for new treatments.

A Data-Driven Approach to Overcoming Clinical Trial Challenges

Tokenization will play a critical role in J&J's RWD strategy. The PHD, one of the most comprehensive electronic healthcare data repositories and the industry's largest chargemaster database, contains electronic medical records and chargemaster billing data from over 1,400 U.S. hospitals and healthcare systems. Through tokenization, Premier can securely link these large datasets providing a more complete, patient-centric view of patient journeys and outcomes while protecting sensitive information.

"The main thing that using tokenized data does is fill data gaps," Johnston said. "No single dataset will fulfill every single need that you have. But when you can tokenize them and link them together, that makes them more powerful. It has a synergistic effect across the databases. Tokenization will allow research that we couldn't have dreamed of five, 10 years ago. And that's really the main benefit of tokenized data."

Through tokenization, Premier can incorporate external data, offering a HIPAA-compliant, multifaceted view of patient health to support real-world evidence submissions approvals. Premier also uses tokenization to enhance data integration, including pharmacy and genomics data, offering comprehensive insights to reduce trial time.

Harnessing Real-World Data for Smarter Clinical Research

RWD powers J&J's insights across multiple domains: understanding the safety and effectiveness of medical devices, characterizing patient comorbidities, analyzing treatment patterns and optimizing clinical trials. The analyses and conclusions that emerge from these insights form the RWE that drives continuous improvement in study design and evidence generation.

"We want to ensure that the trial participants we plan to recruit reflect the demographics of the real-world patient population," Johnston said."That's a big concern for the FDA and other regulatory bodies. They want to make sure that our trials reflect the actual real-world population of patients who are undergoing these procedures."

By converting RWD into actionable RWE, companies can strengthen regulatory submissions and potentially speed the path toward expanded indications. "It's the future for regulatory approvals for medtech," he said. "J&J has been a leader. We have gotten several regulatory successes, and we have several that are ongoing."

Advanced Applications and AI Integration

J&J is exploring new ways to optimize the use of RWD, including large language models to interpret complex hospital billing data. "Each hospital maintains its own chargemaster data," Johnston said. "You could have five different hospitals that describe a single device in 10 different ways. But we are currently testing large language models to sort through the chargemaster data to give us a better, more accurate device identification."

Such efforts, bolstered by the availability of tokenization, are aimed at maximizing the value of RWD for research, development and regulatory purposes, ultimately enhancing the quality of the RWE that informs decisions. The PHD supports this through:

• Scale and breadth: Over 20 years of data from more than 1,400 sites, covering more than 352 million unique patients.
• Diverse coverage: Includes inpatient and outpatient visits, ambulatory care, medication and device utilization and all payer types - from cash to commercial, Medicare and Medicaid.
• Actionable insights: Enables analyses across clinical, financial and outcomes domains including epidemiology, disease states, resource utilization and healthcare economics.
• Support for innovation: Helps generate external control arms, identify optimal trial sites and predict which patients are likely to benefit most from specific procedures or devices.

Transforming Patient-Centric Care

By integrating tokenized RWD into their workflows and translating it into actionable RWE, J&J is reimagining the possibilities for RWE: Studies reflect real-world populations, evidence generation moves more quickly, and the data yield deeper, more clinically-meaningful insights.

For Johnston, the future of RWE innovation is clear: leveraging tokenized RWD will not only enable and accelerate approvals but also to help ensure better patient outcomes, informed by data that reflects the full complexity of patients' health.

For more:

This is just one example of what's possible when real-world evidence is done right. Learn more about what a collaboration with the Premier Applied Sciences team can unlock for your RWE and regulatory strategy.

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Note: Opinions expressed by Stephen Johnston are his own and not the official policy of Johnson & Johnson.