Basics of Clinical Research and Biostatistics
Basics of Clinical Research and Biostatistics

Course Leadership
Luca Bertolaccini, IT and Isabelle Opitz, CH/DE
Welcome to the online course “Basics of Clinical Research and Biostatistics,” designed to provide a solid foundation in clinical research methods and biostatistical principles, with a special focus on oncology.
Throughout the course, participants will:
- Understand the fundamentals of clinical research, including ethical considerations and the role of institutional review boards.
- Explore patient-reported outcome measures and the importance of surrogate endpoints in cancer research.
- Deepen their knowledge of epidemiological methods and evidence-based medicine (EBM) in oncology.
- Learn techniques for data collection, literature review, meta-analysis, and the editorial process.
- Gain practical skills in statistical analysis, from basic concepts to advanced methods and the use of R software.
- Develop scientific writing abilities, from drafting research protocols to publishing manuscripts using the IMRaD structure.
This course is ideal for professionals who wish to strengthen their expertise in clinical research and biostatistics, benefiting from a multidisciplinary and international approach.
To further enhance your skills in this area, we also recommend participating in the following online course: Writing Methodology Course: how to produce high-quality research papers
COURSE DELIVERY
This online course will be delivered through pre-recorded lectures available on demand.
Accreditation
Participants will be issued a certificate of attendance via email (minimum attendance: 75%) on completion of the online evaluation questionnaire and learning assessment test.
Recognition of this course and 8 CME credits has been awarded by the Accreditation Council of Oncology in Europe (ACOE). The American Medical Association (AMA) and the Accreditation Council for Continuous Medical Education (ACCME) designate a maximum of 1 AMA PRA Category 1 credit per hour of activity for this type of educational program.
ESO College Membership
The course allows ESO College members to earn college credits, helping them advance within the College and unlock additional benefits. By fully and actively participating in the course, members will receive 3 College credits.
Registration
Registration to the course is free but mandatory. Registration will be confirmed by e-mail.
Contacts - Organising secretariat
Introduction to Clinical Research
Ethical considerations and institutional review boards
Virginia Sanchini (IT)Why, what and how of patient reported outcomes measures in oncology
Oriana Ciani (IT)The pitfalls of surrogate endpoints in cancer research
Rod Taylor (UK)Principles of Clinical Epidemiology and Evidence-Based Medicine
Types of epidemiological studies
Gonzalo Varela (ES)Evidence-Based Medicine in Oncology Research
Massimo Di Maio (IT)Literature Search and Review Methods
Data collection methodologies and tools
Dania Nachira (IT)Meta-analysis and systematic review methodologies
Honoria Ocagli (IT)The editorial process and evaluation of a manuscript
Matthias Siepe (CH)Statistical Methods in Clinical Research
ABC of Statistics
Urania Dafni (GR)Advanced statistical analysis methods
Introduction to statistical analysis with R software for cancer scientists
Livio Fenga (IT)Writing and Publishing Research Findings
How to write a research protocol
David Boulate (FR)
Dania Nachira
Fondazione Policlinico Universitario A.Gemelli IRCCS, Thoracic Surgery Dpt., Rome, IT
David Boulate
Hôpital Marie Lannelongue, Research and Innovation Unit, Le Plessis-Robinson, FR
Gonzalo Varela
Salamanca University Hospital, Salamanca University Hospital, Santa Marta de Tormes, ES
Honoria Ocagli
Laboratory of Systematic Review and Evidenced Medicine, University of Padova, Padova, IT
Livio Fenga
ISTAT - Italian National Institute of Statistics, Department for data collection and development of methods and technologies for the production and dissemination of statistical information, Rome, IT
Manuel Carnero Alcázar
Hospital Clínico San Carlos, Surgery, Madrid, ES
Massimo Di Maio
Università degli Studi di Torino, A.O.U. Città della Salute e della Scienza di Torino, Director, SC Oncologia Medica 1U, Torino, IT
Matthias Siepe
Inselspital, Universitätsspital Bern, Universitätsklinik für Herzchirurgie, Bern, CH
Oriana Ciani
Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Research Dept., Milan, IT
Rod Taylor
University of Glasgow, Institute of Health and Well Being, Glasgow, UK
Urania Dafni
National and Kapodistrian University of Athens, Public Health Dpt., Goudi-Athens, GR
Virginia Sanchini
Milan, IT