Observational clinical research has become a fundamental tool for the development of new health technologies through the observation of what happens in actual clinical practice.
Observational studies are extremely heterogeneous since they include very different designs and aims. Unfortunately this type of study is only partially regulated, both at a local and international level. This causes some difficulties in the planning of the ethical and authorisation process, and in the conduction of the study.
Designing and carrying out an observational study requires, besides a depth knowledge of legal constraints and of the legislative framework, specific methodological and epidemiological skills. The use of the traditional operative models borrowed from controlled clinical trials is not the solution. To identify the right solutions it is important to adapt to every single project the huge amount of available techniques and instruments.
Who should attend?
The course is aimed at everyone who works in biomedical or pharmaceutical companies and needs to plan and design an observational clinical study.
Experience in Medical Affairs, Clinical Developmentor Late Phase Clinical Research.
Specialists from Market Access and from Health Economics and Outcome Research (HEOR) are also welcomed
03 April: Definition, applications and regulations
- Clinical Observational Research and the need of Real World Evidence
- Post marketing studies (Registries, PASS / PAES, DUS, etc.)
- Pre marketing studies (disease, epidemiological, etc.)
- Regulations and international standards
- EMA (European Medicines Agency) Guidelines
- References for the treatment of personal data
04 April: How to design a study?
- Why design and conduct an observational 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 of an observational study
Lessons with case studies and classroom exercises.
At the end of the training you will be able to:
- identify the key success factors that characterize the design and the outcome of an observational study.
The course will be taught by two senior consultants of MediNeos Observational Research under the scientific responsibility of Giovanni Fiori.
MediNeos is specialized in the design and management of multicenter, international observational studies and patients registries for the Life Sciences Industries.
Giovanni Fiori, Managing and Scientific Director
A PhD in Human Population Biology research (Bologna University) Fiori has also a Master degree in Public Health from the Catholic University “Sacro Cuore” (Rome). He has participated in epidemiological researches in Italy and managed numerous research campaigns abroad as part of International cooperation programs promoted by the University of Bologna. Since 2005 he has been coordinating the “Observational Studies” Working Group of SSFA (Società di Scienze Farmacologiche Applicate) where he has twice been a member of the Board of Directors. He is in charge of the EUCROF(European CRO Federation) “Late Phase” working group and an active member of SISMEC (Società di Statistica Medica e Epidemiologia Clinica), SIF (Società Italiana di Farmacologia), ISPE (International Society of Pharmacoepidemiology) and ISPOR (International Society for Pharmacoeconomics and Outcomes Research). He has authored or co-authored over one hundred scientific papers and articles at National and International level.
MediNeos Senior Consultants:
Lucia Simoni, Clinical Data Management and Biostatistics Unit 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.
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.
Filip Rozewski, Real World Data Advisor
Filip Rozewski holds a Master’s Degree in Pharmaceutical Sciences from the University of Warsaw and Hamburg. He had been working both in the industry and in non-governmental organizations. Now he is working in MediNeos and he is heavily involved in the robust area of real-world research, which brings together all his professional interests: clinical pharmacology, epidemiology and public health.
MediNeos strives for constant improvement in the application of proper epidemiological methods geared to collecting reliable and significant health data in both pre and post marketing phases, covering the most important therapeutic areas. With a track record of over 100 successful observational studies managed since 2003, MediNeos has developed a vast and specific experience in Real World Data collections performed with a variety of prospective, retrospective and hybrid designs.