Beyond the Stomach: Exploring the Role of Helicobacter pylori in Pushing Precancerous Lesions to Colorectal Cancer and the Therapeutic Potential of Probiotics.

Real-world data (RWD) and the real-world evidence (RWE) derived from it have moved from the margins to the centre of decision-making about medicinal products (). Over the past decade, both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have developed dedicated frameworks for integrating RWE into regulatory submissions, reflecting a recognition that evidence generated outside controlled trial settings can address questions that trials alone cannot. It is of utmost importance that RWE is not replacing randomized controlled trials (RCTs) but rather becoming an increasingly important component of evidence-based decision-making although evidence on the safety, effectiveness and value of medicines is traditionally generated mainly from RCTs (; ). There is growing consensus that appropriately conducted RWD studies can complement RCTs and fill critical evidence gaps, particularly in populations, settings, and time horizons that trials rarely accommodate, including long-term outcomes, real-world effectiveness, and comparative safety in patients with multimorbidity. Today, regulators, health technology assessment (HTA) bodies and payers increasingly draw on data generated in everyday clinical practice (; ; ) a trend reinforced by the EMA’s 2023 RWE framework and by a proliferation of guidance from regulatory and HTA agencies across North America, Europe, and the Asia-Pacific region, and, crucially, on data and preferences contributed by patients themselves, with patient-reported outcomes and patient experience data now increasingly embedded in submissions to regulatory and HTA bodies worldwide, to address questions that RCTs leave unanswered (; ). This third volume of the series continues a conversation that earlier volumes began: how can patient-centric methods turn the growing abundance of routine and patient-generated data into evidence that genuinely improves policy and care? The Research Topic set out to assemble work that applies patient-centric methodologies across the medicinal-product life cycle: the design of studies using RWD and patient-generated data, the analysis of patient subgroups, outcome measurement that reflects patient experience and preference, integration of patient data with disease registries, and stakeholder collaboration that converts data into decisions. The seventeen contributing articles span methodological translation, the elicitation of patient preferences, comparative effectiveness and safety, evidence synthesis, economic modelling, and the evaluation of national policy. Collectively they illustrate both the promise of RWD and the practical, methodological and governance challenges that determine whether that promise is realised in real life practice. A recurring message across the volume is that generating RWD is only the first step; the harder task is making it usable for those who make the decisions. examine how academic RWD research produced within the European HTx project translates into practical HTA, drawing on case studies across disease areas, treatments and data sources to show where academic methods meet, and fall short of, the operational needs of assessment agencies. turn to the systemic barriers that constrain RWE uptake for drug regulatory affairs and market access in Saudi Arabia, mapping the data-quality, capacity and governance obstacles common to emerging RWE ecosystems. Policy itself becomes the object of study in the interrupted time-series analysis by , which quantifies how China’s national volume-based procurement programme reshaped the use and expenditure of platinum-based antineoplastic drugs. Together these papers connect data infrastructure to the institutions that must act on it. A point to note is that policy evaluation should consider not only utilization and expenditure but also patient access, patient outcomes, quality of care, and system sustainability.