Office of the Chief Medical Officer

The Power of Real-World Data to Enhance Safety

The Office of the Chief Medical Officer believes in the collective power of real-world observational data to complement clinical trial findings, and in sharing our insights to improve health outcomes.

We actively collaborate, responsibly share de-identified data from studies involving primary data collection, where possible, and welcome other researchers to build upon our knowledge. We also publish our findings widely and openly support and facilitate the registration of studies.

To leverage the power of big data and analytics, we launched an open science collaborative with Columbia University called the Observational Health Data Sciences and Informatics (OHDSI). OHDSI is a multi-stakeholder and multidisciplinary open community of researchers working together to generate reliable evidence from observational data to promote better health decisions and better care. All findings, methods, analysis code and related software tools are shared publicly and published with free access to advance public health.

The OHDSI community comprises 60+ databases representing more than 1.2 billion patients i­n 20+ countries and has developed several open-source tools for data analysis and visualization.

Read a Q&A with Jesse Berlin, Sc.D., Vice President and Global Head of Epidemiology, Johnson & Johnson, on how our scientific and evidence-based approach to real-world evidence helps define patient and consumer outcomes.

Leveraging big data to create a more transparent model for real-world data

Johnson & Johnson continues to break new ground in using real-world evidence (RWE) to analyze large data sets in order to improve patient care. Using open-source tools through our OHDSI collaboration, in 2018, we analyzed the anonymized data of more than 700,000 adults with type 2 diabetes across four large databases to evaluate comparative effects of seven diabetes medications or classes of medications on the risk of amputation and hospitalization for heart failure.

The study, OBSERVE-4D, is the largest and most comprehensive real-world observational study to date of its kind, and demonstrates Johnson & Johnson’s ability to conduct such research thoroughly, quickly and with extraordinary transparency. It demonstrates an innovative approach to transparency that included preregistration of the protocol, public posting of the protocol as well as the source programming code and establishing a website to allow anyone to explore the extensive results set of over 10,000 effect estimates. OBSERVE-4D established a new standard for quickly and appropriately translating large-scale real-world data into evidence to complement evidence from clinical trials in an open and transparent manner.

We also facilitate RWE research and collaboration around the world. For example, in Asia, we established the China Real-World Healthcare Data Collaboration, a network of databases from five major tertiary hospitals covering more than 15 million individuals, significantly enhancing possibilities for faster, better medical decisions.

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