Why take this course?
Real World Evidence (RWE) is among the most frequently discussed topics at professional medical conferences and meetings. It refers to the systematic and unbiased collection of data used for decision making that are not collected in conventional randomized controlled trials. At the same time, the patients’ perspective has never been more important in the evaluations of medical products and in effectiveness research. Patient Reported Outcomes (PRO) play a key role in capturing real world data that reflect patients’ needs and values.
The course will provide an extensive coverage of PRO-related topics with a particular focus on the use of PROs for Real World Evidence Generation.
Who is this course for?
The course is intended for professionals of the life-science industry working in Medical Affairs, HEOR, Market Access, Clinical Research, Real World Evidence generation, Clinical Operations, Biostatistics, Data Management
The course program will focus on the following topics:
• Use of PROs in observational research studies
• Typical domains of PROs
• Validation of a PRO
• Choice of a PRO
• Digitalization of PROs
• Statistical considerations
• Regulatory aspects
Lectures, quiz and workgroup exercises
At the end of the training, you will be able to…
Course attendees will gain a significant understanding of use, ideal properties, types, development and evaluation of PRO instruments in a context of Real World Evidence generation.
Stefano Viaggi is Director 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 multicentre, international observational studies and patient registries. With a special talent for innovation and strategic thinking, he 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 at the University of Padua, is co-author of several clinical research and epidemiologic papers and has a special interest in digital technologies