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.
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.
Simona Sgarbi, Real World Data Senior Advisor
She holds a MS in biophysics. Since 2002 she has been working in MediNeos where she gained expertise in epidemiology, biostatistics, laws/regulations applied to pharmaceutical and medical devices fields as well as project management of complex multinational peri and post approval studies. She highly skilled in the design of observational studies with different study designs (prospective and retrospective cohort studies, case control, cross sectional) and various typology (Epidemiological Studies, Patient Registries, PASS/PAES, …). She is author of several scientific publications and lectures both at national and international congresses. She is an active member of different national and international scientific associations.
Fabio Ferri, Epidemiology and Outcome Research Specialist
Graduated in Biomolecular and Cellular Sciences at the University of Ferrara. After having carried out international university research conducted on bioinformatics applied to molecular oncology, he continued his career as a Biostatistician in the field of observational studies, in the areas of oncology, respiratory and allergological diseases. Involved at various stages of the development and conduction of clinical studies, he has skills in designing observational studies, study protocol writing, planning and implementation of statistical analysis in SAS, statistical reports and clinical reports, publication of results, and evaluation of psychometric properties of questionnaires. He is also lecturer in webinars and training courses on statistical and epidemiological methods.
Lucia Simoni, Epidemiology and Outcome Research Specialist BU Manager
She obtained a MS degree in Statistics and a PhD in Population Genetics. Moreover she completed a 2-year post-doctorate. She has been working in MediNeos since 2003 as biostatistician and currently is manager of Clinical Data Management and Biostatistics Unit. She is responsible for ensuring the highest possible quality control in recorded clinical data and for developing strategies to optimize such processes. She also has deep experience in designing studies and in the validation process of PROs. She is author of several scientific publications and lectures both at national and international congresses.