Nowadays, Real World Data (RWD) is a fundamental tool for the development & value’s demonstration of new healthtechnologies, through the evaluation of what happens in actual clinical practice. Methods to generate Real WorldEvidence by means of RWD are extremely heterogeneous since they include many different types of study design, study typologies and data sources. However, all types of RWD collections, with the only exception of the PragmaticTrials, share the same common methodology: the observational method. As a consequence, in order to design
and successfully execute a RWD collection, it is essential to handle the principles of epidemiology and outcome research and to have a very good knowledge of observational methods. Moreover, since this type of research activity is only partially regulated, both at local and international level, it is also required a basic knowledge of certain legal constraints. Finally, from an operational point of view, it is important to be aware that the use of the traditional operative models borrowed from classical clinical studies is not the right solution. The aim of this two-day intensive course is to explore the methodological and technical connections between RWD and observational methods and to share the most critical and successful factors for designing researches to generate Real World Evidence. Using very interactive methods, including some class exercises, the participants will learn how to successfully conduct a RWD collection, starting from the definition of a well-defined research question, followed by the design of a research model which will focus on the product’s business strategy, legal &
ethical constraints and the methodological standards.
Who should attend?
The course is aimed at everyone who works in Life Science industry, such as pharmaceutical, medical devices companies and biotech, and needs to design and/or execute a Real World Data collection based on observational methods aimed to define or secure the product value in a pre and/or post marketing phase of the product life cycle.
Experience in Medical Affairs and/or Clinical Development. Specialists from Clinical Operations, Market Access, Health Economics and Outcome Research (HEOR) are also welcomed
27 November: Definitions, applications and regulations
- Real World Data (RWD) and the need of Real World Evidence
- Methodological background of RWD and Outcome Research (OR): the observational methods
- RWD/OR in Pre Marketing phase (burden of disease, epidemiology, patients’ journey, etc.)
- RWD/OR in Post Marketing phase (PASS/PAES, DUS, CER, etc.)
- Regulations and international standards impacting RWD/OR using observational methods
28 November: How to design a study?
- Strategic approaches to Real World Data
- How to define the “Research Question”
- Advantages and Disadvantages of the main Study Designs
- How to deal with Confounders
- Communication of the results
Interactive lessons with case studies and classroom exercises
At the end of the training, you will be able to:
…identify the key successful factors that characterize the design of a real world data collection based on observational methods.
Simona Sgarbi – Senior Real World Evidence Lead | Lundbeck
Simona holds a MS in Biophysics. Since 2002 (when she joined Medineos-an IQVIA company), she has been working in Real World Evidence research focusing on methodology and laws/regulations within the pharmaceutical and medical device fields. This has involved the project management of complex multinational peri- and post-approval studies. She is highly skilled in connecting the product development strategy with the design of observational studies (including prospective and retrospective cohort studies, case control, cross sectional) and various typology (such as epidemiological studies, patient registries, PASS/PAES, MCR, etc.). She has authored several scientific publications in peer-reviewed scientific journals and presented lectures for both national and international congresses. She is an active member of international scientific associations, including ISPOR (International Society of Pharmaco-economics and Outcomes Research).
Recently, she has joined Lundbeck as Senior RWE Lead within the HEOR & RWE Medical Affairs Department, based in Copenhagen.