Discover the course
Real-World Data and Real-World Evidence
An intensive Lab Workshop to learn the main concepts behind Real-World Evidence and Observational Research and to design innovative studies that generate evidence
Nowadays Real-World Data (RWD) are an essential tool to develop and show the value of new health technologies through the observation of what happens in a real clinical setting. Real-World Evidence (RWE) gives us an excellent opportunity to better understand diseases, patients’ needs and improve health processes. The promise of RWE is that a rich diversity of data collected from extremely large patient samples will produce more precise, targeted and more effective healthcare treatments on an individual patient level. The methodology to generate RWE can very much differ from one study to the other, since one may use different study designs and data sources. However, all RWE projects, with the sole exception of pragmatic trials, have the scientific methodology in common with observational studies. For this reason, a solid knowledge of the principles of observational research, and of its distinctive characteristics as compared to interventional clinical trials, will provide participants with a sound methodological background to approach RWE projects. During this 2-days course, we will address methodological and contextual aspects of observational research, insights on specific types of projects and on the impact of new technologies in the field. Observational research is only partially regulated - both locally and internationally - so a basic knowledge of some ethical and regulatory constraints is also required in order to properly design RWE studies. The experience and perspective of a relevant Ethics Committee will help participants to consolidate their knowledge to appropriately design and conduct observational research. The quality of the evidence produced by observational research will also be analysed based on the perspectives of the different guidelines and tools that are used to study evidence from the perspective of the payer and of companies willing to liaise with payers.
DAY 1 - Trainer: S. Viaggi
REAL-WORLD EVIDENCE RESEARCH METHODOLOGY
- The context of Real-World Evidence
- Real-World Evidence and Observational Research
- Project and study design in Observational Research
- Sample size and Bias
- Retrospective Observational Research
- Overview of the different types of RWE projects
- From Real-World Data to artificial intelligence: what Machine Learning can offer
DAY 2 - Trainers: A.C. Frigo, S. Viaggi
REGULATIONS GOVERNING OBSERVATIONAL RESEARCH
- Regulations and data privacy in observational research
- The Ethics Committee perspective: practical experiences
- Advertising and promotion of observational research
- Guidelines to evaluate scientific evidence
Workgroup: interactive exercise of Design Thinking
She has a Bahcelor’s degree in Statistical Sciences at the University of Padua. She has worked in the pharmaceutical industry taking part in the drafting of research projects and in the analysis of results. She has also worked at The Italian National Institute of Statistics (ISTAT) as a researcher for the 2000 Census and finally at the University of Padua where she has been an associate professor since 2015.
She has co-authored over 150 scientific articles mainly in the cardiology, hepatology and paediatric fields. She has been a member of the Clinical Research Ethics Committee of Padua since 2005, which she has chaired since the end of 2013. Finally, since 2010 she has been a member of the Ethics Committee for Animal Experimentation of the University.
Stefano Viaggi (Bachelor’s degree in Statistical Sciences at the University of Padua) has over 30 years of experience in experimental and observational clinical research and has designed or taken part in more than 200 research, communication and training projects for multinational companies in the Life-Science sector.
He is a professor at university master’s degrees and a trainer on Real-World Evidence, research and innovation methodology for companies. He is the founder and principal consultant of CLUELL, a consultancy company for the Life Science sector specialized in data science and collective intelligence projects.
To all those who work in the Life Science field within pharmaceutical, medical device or biotech companies and find themselves in the need to promote, design or conduct Real-World Evidence projects to generate evidence and support the value of their products. To professionals operating in the fields of medical affairs, clinical research, market access, RWE and / or in all areas involved in the strategic planning of innovative data-driven projects to generate scientific evidence.
The course consists of interactive lecturing sessions combined with experiential focus workshops. Participants will live the experience of a lab workgroup - inspired by the Design Thinking methodology - in which they will compare, and experience innovative solutions based on the concepts addressed during the course.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.535,00* (until 21 April 2020)
Ordinary: € 1.755,00*
Freelance - Academy - Public Administration: € 810,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, April 21, 2020
At the end of the training, you will be able to
Know which are the keys for the successful design of a Real-World Evidence project
Liaise with in-house and external stakeholders on Real-World Evidence
Identify the appropriate methodologies to design and conduct Real-World Evidence innovative projects