The power of real-world data to deliver more for patients
Real-world data (RWD) are health data gathered outside a controlled clinical trial environment from sources like electronic health records, health insurance claims and even wearables. Translating RWD into robust, reliable real-world evidence (RWE) has the potential to transform the practice of health care and improve health outcomes for people around the world.Expand
Typically, new medicines and medical devices are tested for safety and effectiveness in laboratories and in clinical trials among a relatively small group of patients who meet certain study-defined criteria. The availability of new RWD sources combined with advanced analytical methods now makes it possible to understand how a product works in much larger populations, across many different types of patients, in a variety of clinical settings, and over many years. As a result, RWD can help inform care and treatment decisions that are both more targeted and applicable to broader groups of patients.Collapse
How the Office of the Chief Medical Officer is using real-world data
The Epidemiology team in Johnson & Johnson’s Office of the Chief Medical Officer (OCMO) is breaking new ground in RWE research.Expand
We are using real-world data to:Collapse
- Better understand diseases and how patients experience them
- Evaluate how products that were tested in controlled clinical trials and preclinical studies perform when used in clinical practice in large, diverse populations
- More rapidly assess and communicate the safety and effectiveness of our products
- Inform and expedite regulatory reviews to help get new, potentially life-saving medicines and medical devices to patients faster
- Help healthcare providers decide when and how to use our products at the point-of-care
- Understand patient preferences and benefit-risk considerations to enable more patient-centric product development
- Support the development of patient-centric research practices and policies
As Johnson & Johnson’s Vice President and Global Head of Epidemiology, Josh Gagne and his team study real-world data to further understand the safety and effectiveness of our products across many different kinds of patients and clinical environments to help inform important decisions that ultimately improve care for patients
Leading real-world data innovation to advance better care
As part of Johnson & Johnson’s commitment to patients, we believe we have a responsibility to advance the science behind RWE to help deliver even more value for patients. Our team of leading epidemiologists and data scientists around the world is developing novel research methodologies and collaborating with regulators, healthcare providers, and other scientists to accelerate important RWE research beyond Johnson & Johnson.
Johnson & Johnson is a founding partner of the Observational Health Data Sciences and Informatics (OHDSI) Network. OHDSI is a unique collaborative home to 3,200+ collaborators in 80 countries working together to expedite high-quality real-world evidence to answer critical clinical and public health questions.
We co-led the Innovative Medicines Initiatives PREFER project to develop a framework on how and when to use patient preferences in benefit-risk assessments of medicinal products. The framework received formal qualification from the European Medicines Agency (EMA) in 2022.
Johnson & Johnson led four pioneering test cases as part of the US FDA National Evaluation System for health Technology (NEST) Initiative. NEST seeks to support the generation and use of timely, reliable, and cost-effective real-world evidence throughout the medical device lifecycle.
Johnson and Johnson’s Epidemiology team studies the safety of our products using real-world data to complement evidence from controlled clinical trials. Results from these studies are published so doctors, patients and other stakeholders can use the findings to inform important medical decisions.
More news from the Office of the Chief Medical Officer
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With health insurance enrollment season in full swing, you may be researching which plan to get—and signing those data disclosure forms. But have you ever wondered how some of that info is used once you sign on the dotted line?