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 , such as pharmaceutical, medical devices companies and biotech, working in Medical Affairs, HEOR, Market Access, Clinical Research, Real World Evidence generation, Clinical Operations, Biostatistics, Data Management department.
Participant experience Basic understanding of clinical research for the life-science industry
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.
Giovanni Fiori, Managing and Scientific Director
A PhD in Human Populations Biology (Bologna University), Giovanni has also a master’s degree in Public Health from the Catholic University “Sacro Cuore” (Rome). He managed epidemiological research campaigns in the framework of large international cooperation programs in Central Asia. Since its foundation, he is the Scientific Director of Medineos (previously MediData), in charge to define the strategy for designing and conducting more than 120 local and international studies collecting Real World Data for Life Science Industries and no-profit organizations. Since 2005 he has been coordinating the “Observational Studies” Working Group of the Society for Applied Pharmacological Sciences where he has also been a member of the Board of Directors. He is the chairman of EUCROF (European CRO Federation) “Late Phase” working group. He teaches regularly at the Master in Clinical Research of Milano Bicocca University. Invited speaker at several congresses, he has been authored or co-authored over one hundred scientific papers and articles.