Prioritizing patient-centered safety science innovation
Continued innovations in healthcare require a heightened focus on patient safety. Novel treatments, technologies, and care models promise to improve patient outcomes but can also introduce new patient safety challenges. With people more informed and engaged in their health decisions, expectations on access to and reliability of information increases, making patient-focused approaches to medical safety increasingly important.Historically, the healthcare industry has focused on understanding the profiles of their products or devices, more so than the patients who use them. Yet, data show that when patients are treated as partners in their care, significant gains are made in safety, patient satisfaction, and health outcomes. Today, there is an intentional shift underway to uplift the patient voice and encourage the pharmaceutical and medtech industry to more closely partner with patients to advance safety science innovation to improve health outcomes.
Closing the Patient-Centered Safety Science Innovation Gap
Traditional safety science approaches may lack the direct integration of patient perspectives and real-world experiences. Today, companies are changing the way they work to meet the changing needs of patients – from doing things for patients to doing things with patients. For example, working to:
- Gather real-world data to understand how a medicine or product is working outside the clinical trial environment
- Develop novel approaches to benefit-risk assessments and patient preference studies
- Collaborate with regulators, trade groups and other partners to inform patient-centric safety research policies
Collaborating to Advance Patient-Focused Decision-Making
In healthcare, collaboration and knowledge-sharing have become critical to help improve patient care worldwide to advocate for and advance patient-focused decision making.
For example, recently, Johnson & Johnson researchers worked with the Innovative Medicines Initiative to develop a framework for patient preference studies that was qualified by the European Medicines Agency (EMA). This enabled a more explicit pathway for stakeholders to engage with the EMA on conducting patient-focused, structured benefit-risk assessments and helped to grow the acceptability of such studies as part of clinical and regulatory decisions worldwide.
Additionally, its Global Epidemiology team recently secured FDA approval of a label extension for a medical device using comparative safety and effectiveness evidence generated exclusively from electronic health records. This was a first for Johnson & Johnson and the medtech industry. This achievement was made possible through collaboration with the Medical Device Innovation Consortium and the FDA’s National Evaluation System for Health Technology Coordinating Center (NESTcc) initiative to advance real-world evidence in regulatory decision-making for medical devices.
In recognition of World Patient Safety Day, we encourage the healthcare industry to stand with the World Health Organization to raise its voice to advocate for patient safety as a global health priority. The company’s ongoing collaborations with stakeholders across the healthcare sector enable it to advocate for and drive forward a more patient-centered, proactive, and inclusive approach to safety science innovation and regulatory decision-making – ultimately benefiting patients worldwide.
To learn more about the Johnson & Johnson’s Office of the Chief Medical Officer approach to patient-centered safety science innovation, please visit: https://www.jnj.com/office-chief-medical-officer.
Josh Gagne is Vice President and Global Head of Epidemiology, Office of the Chief Medical Officer, Johnson & Johnson
