Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. The growing industry need for broader information on real-world effectiveness and safety—both of which will impact the eventual reimbursement and utilization of new products—is driven by regulators, public and private payers, and prescribers, all of whom seek to better understand the value of a new product in a real-world setting. The result is that real-world evidence is now included earlier in the research and development phase.
Medical chart review (MCR) studies are a research technique in which pre-recorded, patient-centered data are used to answer one or more research questions and are often needed in the absence of suitable healthcare databases and/or other secondary sources of information. Chart review studies facilitate the rapid collection of clinical and healthcare resource utilization (HRU) data and provide tailored, patient-level datasets that are ideally suited as inputs to a wide range of burden of illness, drug utilization, safety, and health economic analyses.
Who should attend?
Medical affairs, market access, HEOR, clinical operations working in biomedical or pharmaceutical companies.
Basics of Observational Research methodology
- A methodologic framework for research from secondary data sources
- Design and management of a Medical Chart Reviews (MCR)
- Retrospective research issues: data privacy and bias
- Workshop exercise and discussion
Lecture + workshop
At the end of the course the participant will be able to…
1. …properly frame the methodology of retrospective observational research within the real-world evidence context;
2. …understand the main traits of retrospective medical chart reviews including legal issues and research biases to properly select when a MCR is the appropriate research tool for real world evidence generation.
Stefano Viaggi is Director of Real World Data Solutions at MEDINEOS Observational Research, a company focused on observational research for the life sciences and specialized in the design and management of multicenter, international observational studies and patients registries. With a special talent for innovation and strategic thinking, Stefano has been working in the pharmaceutical sector for over 25 years, providing statistical/epidemiological consultancy and project design for multinational pharmaceutical companies, Clinical Research Organizations and CME providers. He holds a university degree in Statistics, is co-author of several clinical research and epidemiologic papers and has special interests in digital technologies.