Today we can no longer afford to undertake randomized effectiveness trials that cost tens or hundreds of millions of dollars. But today we also have registries and other powerful digital platforms. Today it may be possible to design and conduct megatrials with what we have: bigger data and smaller budgets.
Real-World Data (RWD) has become a fundamental tool for the development and demonstration of the value of any new health technology, through the observation of what happens in real clinical practice. Real-World Evidence (RWE) is a key opportunity to better understand the disease, patient needs, and to improve healthcare processes. RWE promises that a rich diversity of data collected from extremely large patient samples will produce more precise, targeted, and therefore more effective healthcare at the individual patient level.
An integrated patient-centric perspective among different stakeholders and a focus on continuous evidence generation is the way forward for the life science industry. The methods for generating RWE are extremely heterogeneous as they include different study designs and types and various data sources. However, all RWE projects, with the sole exception of pragmatic trials, share the same scientific methodology as observational research. For this reason, methodological and scenario aspects of observational research will be addressed, as well as insights into specific types of projects and the impact of new technologies in this area. These basics information will be revised to envision how real-world evidence should be incorporated throughout the product’s lifecycle to ensure a significant value during its launch and commercialization.