Our fundamental responsibility is to provide patients, consumers and healthcare providers with products that are safe and effective. Our approach to medical safety is based on evidence and science and driven by ethics and values, putting patient well-being first and foremost in our decision making and actions. The Office of the Chief Medical Officer (OCMO) is a global, functionally independent group of medical and scientific professionals working across J&J to guide excellence in product safety and development across our business.
Key areas of progress in medical safety in 2023 included:
Using real-world evidence (RWE) to improve patient care
RWE, drawn from real-world patient data and experiences, offers a wealth of information that complements traditional clinical trial data relating to the safety and effectiveness of our products. As a result, the use of RWE can enable healthcare decision making by health authorities and other stakeholders, optimize resource utilization and ultimately enhance patient access and medical outcomes. Among the many applications of RWE advanced by OCMO in 2023 to improve patient care, we can note the following:
- Leveraged a comparative RWE study using real-world data exclusively from electronic health records to support the FDA approval of a label extension for the THERMOCOOL SMARTTOUCH cardiac ablation catheter to include treatment of persistent AFib. This product received FDA approval, the first time in the MedTech industry that RWD was used to support a label extension.
- Used an evidence-based scientific approach, including RWD, to streamline pediatric drug development and reduce the exposure of pediatric patients to unnecessary clinical studies. This approach was used to help gain approvals for medicines for use in adolescents in China.
- Accelerated decision making for product safety by developing a machine learning-enabled, rapid-cycle analytics platform for safety signal evaluation that has reduced from months to days the time it takes to generate regulatory-grade RWE to estimate treatment effects. This platform complements the evidence generated through clinical trials, routine pharmacovigilance and post-authorization studies to deepen our understanding of the safety of our products.
Reducing device-related interruptions in the OR
Device-related interruptions in the OR can increase stress and the potential for errors. J&J continues to work to standardize safety measures in ORs across the globe, having created, in 2018, with Ariadne Labs, the Device Briefing Tool (DBT), a guide that helps OR teams efficiently review the proper use of a device before a procedure, promoting better communication. In 2023, we published new results from a study at two major hospitals in Singapore, that evaluated how the DBT strengthens surgical teamwork, enhances safety culture and improves outcomes for surgical teams. Results showed that the implementation of the DBT, together with the WHO Surgical Safety Checklist, was associated with an 86.5% reduction in device-related interruptions, which suggests improvements in operative efficiency and safety.
Supporting compassionate use
We collaborate with the NYU School of Medicine to support decision making for investigational medicine requests, also known as “compassionate use” or “preapproval access.” The Compassionate Use Advisory Committee (CompAC), comprising ethicists, physicians and patient representatives independently selected by NYU, provides recommendations on preapproval access plans and individual requests. CompAC affirms J&J’s commitment to a transparent, ethical and objective approach to reviewing requests for access to our investigational medicines. In 2023, nearly 2,000 patients received access to our innovative medicines and since 2015, more than 9,000 patients in 91 countries received access to innovative medicines through J&J’s Pre-Approval Access Program.
Assessing external requests for access to data
Since 2014, J&J worked with the Yale University Open Data Access (YODA) Project to enable a consistent approach to the independent assessment of external research proposals that request the use of clinical trial data generated by J&J. In August 2023, we reached a major milestone: 100 scientific publications resulting from independent data requests approved through the YODA Project. In total, at the close of 2023, 366 research proposals were reviewed, and 109 articles were published using data shared through the YODA Project, enabling researchers to create new insights that advance science and medicine and lead to improvements in public health.
