At Johnson & Johnson, patient safety is guided by Our Credo and embedded in our culture—a culture that puts patients first and empowers everyone to act with integrity, transparency, and accountability. Our culture of patient safety motivates us to collaborate with all stakeholders at every stage, from scientific research and development through care delivery and post-market surveillance. We are driven by our shared commitment to develop innovative solutions that address the complex and evolving needs of the patients and communities we serve.
The Office of the Chief Medical Officer (OCMO) pioneers new methods to integrate clinical and safety science, epidemiology, and bioethics into our product development and decision-making processes. Our goal? To make evidence and science-based decisions that prioritize patient safety and well-being.
Here are five ways the OCMO is doing this:
1.
Understanding the patient perspective is critical to developing innovative products that truly meet their needs. At Johnson & Johnson, we work to identify the benefit and safety outcomes most important to patients, the relative importance of those outcomes, and the tradeoffs patients are willing to make between them. We use structured Benefit-Risk assessments, distinct from clinical study results and increasingly valued by regulatory authorities, for decision-making. In addition, incorporating patient preference information into the assessments ensures that the patient’s voice is heard and integrated into the development of our pharmaceuticals and medical devices, making our products not only safe and effective, but also aligned with what patients value most.
2.
Surgeries can be complex, therefore minimizing device-related interruptions in the operating room is essential for patient safety. Johnson & Johnson designs and develops innovative safety tools and implements processes to ensure safe and effective use. For example, the Device Briefing Tool (DBT) developed with our partners at Ariadne Labs supplements the World Health Organization (WHO) Surgical Safety Checklist (SSC), transforming surgical team performance during surgery. This tool improves teamwork and communication among surgical teams by empowering them to be ready and to speak up in the operating room. Concurrent use of the SSC and the DBT, as published in JAMA Surgery showed an 86.7% reduction in device-related interruptions and a significant improvement in non-technical skills, which contributes to better patient outcomes.
3.
Informed decisions are the cornerstone of patient safety. 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. Our teams lead the way in analyzing RWE for regulatory decision-making to allow regulators and health authorities around the world to make more informed safety decisions about both the benefits and safety of our products, ensuring that healthcare providers have the most comprehensive information available when treating patients.
4.
Patient need is a compass, and it is incumbent upon us to follow where it leads. For Johnson & Johnson, it led us to develop a first-of-its-kind Guide to Expanded Access back in 2021. Following feedback from patients and advocates alike, we’ve released an updated edition for 32 countries. This first-of-its-kind Guide to Expanded Access provides patients, caregivers, and physicians much-needed clarity around expanded access – a potential pathway to investigational treatment outside of clinical trials for patients who are ineligible to participate in a trial and whose disease has exhausted all available treatment options. With program requirements and details that vary country by country, expanded access can be challenging to understand and navigate. Guided by our bioethical principles, the Guide to Expanded Access brings to life Johnson & Johnson’s commitment to patient health and safety while enhancing transparency and clarity.
5.
Transparency in clinical research is vital for advancing science and improving patient outcomes. Over the past decade, Johnson & Johnson has partnered with the Yale University Open Data Access (YODA) Project. This first-of-its-kind collaboration allows external researchers to access our clinical trial data, fostering an environment of openness and trust. By sharing access to our data, we are contributing to a broader understanding of medicine and paving the way for new safety insights and innovations.
