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May 12 - May 13
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Y-ECI CLTG and Y-ECI ROSC Webinar Series
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Joint Webinar on Innovative study design in older adults
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Virtual Event
Clinical Trial Statistics
for Non-Statisticians
10 – 13 June 2025, Brussels, Belgium
Develop the statistical knowledge required to better understand today’s cancer clinical trials!
ABOUT
Today, statistics are critical to understand clinical trials. This EORTC course provides an introduction to the statistical methods used for the design, conduct and analysis of cancer clinical trials.
WHY ATTEND?
This course will help participants acquire a greater understanding of the statistical principles whilst avoiding too technical formulations.
Participants will be better equipped to design their own clinical research, work in a multidisciplinary team involving statisticians and to critically appraise the scientific value of published research.
WHO SHOULD ATTEND?
This course is aimed at non-statisticians who work in clinical research or at statisticians with little or no experience in clinical trials.
Clinical Trial Statistics for Non-Statisticians
10 – 13 June 2025, Brussels, Belgium
Programme
Optional Introduction
For those attendees who do not have any basic training in general statistics, an optional half day introduction course to statistics and probability (incl. notions of experiment, random variable, distributions, estimations, hypothesis testing) is organised before the official start of the course.
Tuesday 10 June 2025
Optional introduction to probability and statistics
Wednesday 11 June 2025
Principles of comparative clinical trials
Thursday 12 June 2025
Advanced methods for phase III trials
Friday 13 June 2025
Exploratory studies and adaptive designs
The detailed programme can be consulted below.
Tuesday 10 June 2025
| 13.30 | Registration |
| 14.00 |
Introduction to statistical methods (Part I)
Luc Boone
|
| 15.20 | Coffee break |
| 15.40 |
Introduction to statistical methods (Part II)
Luc Boone
|
| 17.00 | End day 1 of Optional Introduction |
Wednesday 11 June 2025
| 08.30 |
Discussion of homework from Tuesday
Luc Boone
|
| 08.50 | End of Optional Introduction |
Principles of comparative clinical trials
Chair: Murielle Mauer
| 08.00 | Registration and welcome coffee |
| 09.00 |
Welcome and introduction
Murielle Mauer
|
| 09.15 |
General statistical principles
Coralie Poncet
|
| 10.00 |
Trial endpoints and design of phase III trials (part I)
Saskia Litière
|
| 10.30 | Coffee break |
| 10.50 |
Trial endpoints and design of phase III trials (part II)
Saskia Litière
|
| 11.20 |
Time to event endpoints analysis (part I)
Marta Fiocco
|
| 11.50 | Break |
| 12.00 |
Time to event endpoints analysis (part II)
Marta Fiocco
|
| 12.30 | Lunch |
| 13.30 |
Sample size for phase III trials (introduction)
Michal Kicinski
|
| 14.00 |
Stat laboratory: practical sample size calculations
Michal Kicinski
|
| 15.00 | Coffee break |
| 15.20 |
Problems and pitfalls of data analysis and interpreting results
Murielle Mauer
|
| 16.20 |
Quiz
Moderator: Murielle Mauer
|
| 17.00 | Networking reception |
| 18.00 | End day 1 |
Advanced methods for Phase III trials
Chair: Corneel Coens
| 09.00 |
Stat Clinic I
Homework: Paper discussion
Corneel Coens
|
| 09.30 |
Interim data monitoring and early stopping rules (with discussion)
Gareth Griffiths
|
| 10.30 | Coffee break |
| 10.50 |
Introduction to Stat Clinic II (IDMC)
Moderator: Jan Bogaerts
|
| 11.10 |
Stat Clinic II
IDMC: What would you recommend?
G. Griffiths / X. Paoletti, J. Bogaerts / M. Kicinski, M. Mauer / J. Musoro, C. Coens / C. Poncet
|
| 12.10 |
Wrap up of Stat Clinic II (IDMC)
Moderator: Gareth Griffiths
|
| 12.30 | Lunch |
Exploratory studies
Chair: Corneel Coens
| 13.30 |
Quality of life
Corneel Coens
|
| 14.20 |
Design and analysis of phase I studies
Xavier Paoletti
|
| 15.10 | Coffee break |
| 15.30 |
Phase II designs without biomarkers
Jammbe Musoro
|
| 16.20 |
Quiz
Moderator: Corneel Coens
|
| 17.00 | End day 2 |
Exploratory studies and adaptive designs
Chair: Xavier Paoletti
| 09.00 |
Stat Clinic III – Homework: Paper discussion
Gareth Griffiths
|
| 09.30 |
Biomarker based study designs
Raphaël Porcher
|
| 10.30 | Coffee break |
| 10.50 |
Adaptive trials
Christina Yap
|
| 11.50 |
Systematic reviews and meta-analyses
Xavier Paoletti
|
| 12.50 | Lunch |
| 14.00 | Stat Clinic IV: Parallel workshops on selected topics
|
| 15.00 | Coffee break |
| 15.20 | Stat Clinic V: Parallel workshops on selected topics
|
| 16.20 |
Views towards the future
Jan Bogaerts
|
| 16.50 |
Closing remarks
Murielle Mauer
|
The CLINICAL TRIAL STATISTICS FOR NON-STATISTICIANS, Brussels, Belgium 10/06/2025 – 13/06/2025, has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME®) with XXX European CME credits (ECMEC®s). Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity.
Clinical Trial Statistics for Non-Statisticians
10 – 13 June 2025, Brussels, Belgium
Faculty
EORTC Headquarters Brussels, Belgium
Corneel Coens - Co-Chair
Lead Statistician, Statistics Department, EORTC Headquarters
Brussels, Belgium
Corneel Coens is currently working as a lead statistician at the EORTC Headquarters (Brussels, Belgium). As part of his tasks for the EORTC Quality of Life Department, he is involved in various aspects of Quality of Life in oncological clinical trials ranging from instrument validation to design, analysis and reporting of patient-reported outcomes (PROs). He is one of the lead investigators in the international SISAQOL initiative (aimed at standardizing PROs analysis methods) and the designated study statistician for the EORTC Genito-Urinary Group. He is a regular contributor for various EORTC educational courses and has been course director for the Joint FECS/AACR/ASCO Workshop “Methods in Clinical Cancer Research”.
EORTC Headquarters Brussels, Belgium
Murielle Mauer - Chair
Head of Statistics Department, EORTC Headquarters
Brussels, Belgium
Murielle Mauer has a PhD in Pure Mathematics. She was Assistant at the Faculty of Science at the University of Liège from 1995 to 2001 and researcher in the Department of Biostatistics and Data Processing at the University Hospital of Liège from 2001 to 2003. She got a Master degree in Biostatistics at Limburgs Universitair Centrum in 2003. She got practical experience of the design, conduct and analysis of clinical trials in Bristol-Myers Squibb pharmaceutical company from 2003 to 2006. At EORTC, she worked as a research fellow in the Quality of Life Unit. Since 2007, she is the Biostatistician in charge of providing statistical support to the EORTC Gastro-intestinal Tract Cancer Group and to the EORTC Elderly Task Force. In 2025 she was appointed Head of Statistics Department at EORTC.
Université de Versailles
St Quentin & Institut Curie, France
Xavier Paoletti - Co-Chair
Professor of Biostatistics, Université de Versailles – St Quentin/Paris Saclay (UVSQ) & Institut Curie
St-Cloud, France
Xavier Paoletti is a Professor of Biostatistics at the University of Versailles St Quentin and at the Institut Curie, a cancer center, in Paris, France; he is a member of the INSERM 1331 research unit dedicated to the development of statistical methods for clinical trials integrating biomarkers. He is the head of clinical research at Curie that includes investigation, sponsorship and biometry units.
After a PhD on early phase clinical trials, Xavier had several positions at the EORTC, at Bichat University Hospital then at the French NCI and finally in two leading cancer centers, Institut Curie and Gustave Roussy.
His main interests are in the methods for early phase trials with a particular focus on cell therapies trials and paediatric oncology trials; he develops approaches for the design of trials evaluating personalized medicine and the validation of surrogate endpoints. He has also a strong commitment in individual patients based meta-analysis of randomized trials with past achievements in gastric and ovarian cancer. He co-authored more than 160 publications in the field of biostatistics, clinical research and cancer.
Speakers
The list of speakers will be published in early February 2025.
Jan Bogaerts
Director, Methodology Direction, EORTC Headquarters
Brussels, Belgium
Jan Bogaerts graduated from the Free University of Brussels (Belgium) in 1986 with a degree in mathematics and in 1988 with a degree in management. In 1993 he obtained his PhD in mathematics. He joined BMS in 1993 as statistician and was involved in several FDA and EMA submissions.
In 2004 he joined the EORTC as statistician. In 2017, he was promoted Scientific Director. He now oversees the activities of the Medical, the Statistics and the Quality of Life departments.
He has contributed to the development of RECIST. He also serves as permanent statistician of the EMA Scientific Advisory Group – Oncology.
His statistical interests include methodological issues in Progression Free Survival, alternative ways to use changes in tumor measurements and newer technologies that measure disease status as predictive markers. He is also highly interested in closing the gap between clinical trials and day-to-day practice and in increasing scientific learning from merging multiple data sources.
Luc Boone
Statistician, Statistics Departement, EORTC Headquarters
Brussels, Belgium
Luc Boone obtained his MSc of Statistics and Data Science at the University of Leuven in 2021. In January 2022 he started his career as a Research Fellow at the Department of Statistics of the European Organisation for Research and Treatment of Cancer (EORTC). As a research fellow he worked on several research projects within the field of oncology, mainly performing statistical analyses for the involved oncology groups. In that same period, he started his PhD thesis on the topic of dependent censoring in survival analysis within the context of oncology at the Université Catholique de Louvain-la-Neuve, which is still ongoing. In April 2024 he changed roles within the EORTC from Research Fellow to Statistician for the Lung Cancer and Gastro-intestinal Tract Cancer Group.
Marta Fiocco
Professor of Applied Mathematics, Mathematical Institute Leiden University
Leiden, The Netherlands
Marta Fiocco holds a PhD in Mathematical Statistics and is currently the head of the DASPO group on Data Analysis and Survival for Personalised Oncology at the Mathematical institute. DASPO also involves the Leiden University Medical Center, where Marta holds a part-time appointment, and the Princes Máxima Centre for Child Oncology in Utrecht.
Its research focuses on prognostic models for oncology data. The group develops new methodologies for inference on the effectiveness of therapeutic regimens in fighting cancer, and applies and adapts existing statistical techniques to an oncology setting.
The models developed by the DASPO group form an important tool in personalised medicine, where tailored treatment of cancer patients avoids undertreatment of high-risk patients and overtreatment in low-risk patients.
Catherine Fortpied
Lead Biostatistician, Statistics Department, EORTC Headquarters
Brussels, Belgium
Catherine Fortpied obtained a Master Degree in Statistics in 1997. After 10 years of experience in pharmaceutical industry as clinical trial statistician in allergy-immunology and central nervous system therapeutic areas, she joined the EORTC (European Organisation for Research and Treatment of Cancer) in 2008 as senior statistician in charge of the design and analysis of clinical studies in Hodgkin Lymphoma and Head and Neck Cancer. Since 2018 she is lead statistician and has also managerial responsibilities within the Statistics department of the EORTC.
Gareth Griffiths
Director of Southampton Clinical Trials Unit (CTU), University of Southampton
Southampton, United Kingdom
Gareth Griffiths is the Director of the UKCRC registered Southampton Clinical Trials Unit (CTU) and Professor of Clinical Trials based at the Centre for Cancer Immunology at the University of Southampton. Southampton CTU is a Cancer Research UK core funded CTU which works very closely with researchers from across the UK and internationally in developing clinical trials and other well-designed studies. A statistician by training Gareth has developed and conducted numerous phase I-III trials in cancer and early cancer diagnosis studies and is currently Chair of the Cancer Research UK Chief Investigator Training and Support Working Group.
Michal Kicinski
Statistician, Statistics Department, EORTC Headquarters
Brussels, Belgium
Michal Kicinski has a background in mathematics, statistics, and epidemiology. He joined EORTC in 2015 as a research fellow after obtaining his PhD at the University of Hasselt. Since 2017, he has been working as a statistician for the EORTC Melanoma, Leukemia, and Children Leukemia groups. His methodological interests include meta-analysis, generalized pairwise comparisons, and dealing with intercurrent events in clinical trials.
Saskia Litière
Scientific Director, EORTC Headquarters
Brussels, Belgium
Saskia Litière obtained her degree in Applied Mathematics at the University of Ghent (BE) in 2001. In that same year she started her career as a statistician at the Center for Statistics (Censtat), Hasselt University (BE). From 2001 to 2010 she was involved in the reorganization of the MSc in Applied Statistics program, obtained her master’s degree in Biostatistics, worked as statistical consultant, taught several Bachelor and Master level courses in statistics, and successfully defended her PhD thesis on the topic of misspecification in generalized linear mixed models.
In September 2010 Saskia joined the EORTC statistics department. In 2020 she was appointed Head of the Statistics Department and, in Sept 2024, Scientific Director. As statistician, she worked on projects related to breast cancer, sarcoma, endocrine tumors, and malignancies of the genito-urinary tract. In her current position, she oversees the scientific aspects of conducting EORTC clinical research and Statistics, Medical Affairs and Quality of Life departments.
She has worked with Jan Bogaerts on RECIST for more than 10 years and is involved in the ongoing updates of RECIST as a member of the RECIST Steering Committee.
Saskia is one of the course directors of the EORTC-ESMO-AACR Workshop on Methods in Clinical Cancer Research. Also, she is the statistician of several non-EORTC IDMCs (Independent Data Monitoring Committee).
Jammbe Musoro
Senior Statistician, Statistics Department, EORTC Headquarters
Brussels, Belgium
Jammbe joined the EORTC in 2015 after completing a PhD in Biostatistics at the Academic Medical Center, University of Amsterdam. He supports both the Quality of Life and Statistics Departments. Currently, he serves as the statistician for the EORTC Cutaneous Lymphoma and Thyroid Cancer Groups, providing expertise in the statistical design of cancer clinical trials. In his role with the Quality of Life Department, he contributes to the design, analysis, and reporting of studies focusing on quality of life endpoints. Jammbe is actively engaged in quality of life research and leads various projects, including the EORTC Minimally Important Difference project, which aims to establish interpretation guidelines for the EORTC QLQ-C30. He regularly contributes to EORTC educational courses and participates in international collaborative projects like SISAQOL-IMI, which aims to standardize the use, analysis, and interpretation of patient-reported outcome data in cancer clinical trials.
Coralie Poncet
Associate Head of Statistics, Statistics Department, EORTC Headquarters
Brussels, Belgium
Coralie Poncet obtained her Master’s degree in Engineering in agronomics and life sciences from AgroParisTech in France in 2007. She also earned a degree in quantitative epidemiology and statistical methodology. She worked as a statistician in the pharmaceutical industry from 2008 to 2016. She was involved in pharmaco-epidemiological studies and supported HTA submissions, mostly in rheumatology and immuno-oncology therapeutic areas. She joined the EORTC in 2017, providing support for the design and analysis of clinical trials of the breast Cancer Group. In 2024, she was appointed Associate Head of Statistics to provide operational support to statistician’s activities in collaboration with the other departments.
Raphaël Porcher
Associate Professor of Biostatistics at Paris Cité University
Paris, France
Raphaël Porcher is Associate Professor of Biostatistics at Paris Cité University, co-director of the Centre Virchow-Villermé Paris Berlin, and member of the METHODS team of CRESS-UMR1153. He is also Member of the Comité d’Evaluation Ethique / Institutional Review Board of Inserm, Senior Associate Editor for Methods at Clinical Orthopaedics and Related Research, and Associate Editor for Statistics, Artificial Intelligence and Modeling Outcomes at the Journal of Hepatology.
Raphaël Porcher works on methods to identify optimal individualized treatment strategies using real-life observational data, as well as principled approaches to evaluate their performance and potential impact. He participates in the teaching and training of medical students in AI and machine learning, and in interdisciplinary programs on AI and health.
Christina Yap
Professor of Clinical Trials Biostatistics, The Institute of Cancer Research
London, United Kingdom
Christina Yap is a Professor of Clinical Trials Biostatistics and Group Leader of Early Phase and Adaptive Trials at The Institute of Cancer Research in London, UK.
Christina is a Statistical Methodologist and Clinical Trialist with over 20 years of experience in the statistical design and analysis of clinical trials. Her expertise includes the development and practical implementation of efficient designs and analyses, serving as the lead statistician for more than 20 trials. This encompasses adaptive designs in early phase dose-finding trials as well as multi-arm multi-stage Phase II/III trials, with a focus on Bayesian approaches. She is also dedicated to advancing the integration of patient-reported outcomes (PROs) in early phase trials to enhance decision-making and promote patient-centered care, leading international initiatives in PRO research. She is also deeply committed to improving the transparency and quality of trial protocols, statistical analysis plans and publication of trial results. She has been involved in several international initiatives developing consensus-based guidance, including leading the SPIRIT and CONSORT extensions for dose-finding trials.
Christina actively serves on funding panels, including the Cancer Research UK Clinical Research Committee. Professor Yap co-leads the Precision Medicine Working Group within the UK Trials Methodology Research Partnership and the NIHR Statistics Group – Early Phase Trials.
Clinical Trial Statistics for Non-Statisticians
10 – 13 June 2025, Brussels, Belgium
European Accreditation
What is CME?
CME (Continuing Medical Education) can be defined as educational activities which serve to maintain, develop and increase the knowledge, skills and professional performance that physicians and allied health professionals use to provide services for patients, the public or the profession.
What does European Accreditation mean for you?
CME accreditation granted by the UEMS-EACCME® provides a guarantee to participants from all over the world that the content of the CME provided is of a high quality, unbiased and didactic and, for European doctors, that this quality will be recognised in their home country.
UEMS-EACCME® Accreditation
The CLINICAL TRIAL STATISTICS FOR NON-STATISTICIANS, Brussels, Belgium 10/06/2025- 13/06/2025, has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME®) with XXX European CME credits (ECMEC®s). Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity.
Further details about CME credits for the course will be published in early 2025.
The CLINICAL TRIAL STATISTICS FOR NON-STATISTICIANS, Brussels, Belgium 11/06/2024 – 14/06/2024, has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME®) with 20.5 European CME credits (ECMEC®s). Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity.
Through an agreement between the Union Européenne des Médecins Spécialistes and the American Medical Association, physicians may convert EACCME® credits to an equivalent number of AMA PRA Category 1 CreditsTM. Information on the process to convert EACCME® credit to AMA credit can be found at www.ama-assn.org/education/earn-credit-participation-international-activities.
Live educational activities, occurring outside of Canada, recognised by the UEMS-EACCME® for ECMEC®s are deemed to be Accredited Group Learning Activities (Section 1) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada.
Conflicts of interest
Conflicts of Interest were reported by:
Gareth Griffiths:
Receipt of grants/research supports: research grants from the National Institute for Health and Care Research, Cancer Research UK, Janssen-Cilag, AstraZeneca, Novartis, Astex, Roche, Heartflow, Celldex, BMS, BioNTech, MSD, IntraOp, Synairgen, Blood Cancer UK, Asthma and Lung UK, UKRI, The Wellcome Trust, NHS England, Unitaid, Imugene, and GSK for unrelated academic clinical trials and programme funding.
Receipt of honoraria or consultation fees: consultancy fees from AZ and AbbVie for delivering CPD training courses.
Xavier Paoletti:
Receipt of honoraria or consultation fees: MSD, Merck and Daiichi-Sankyo
Christina Yap:
Receipt of grants/research supports: Duke Street Bio
Receipt of honoraria or consultation fees: Merck, Trogenix, Bayer
No Conflicts of Interest were reported by: Marta Fiocco and Raphaël Porcher
The following Invited Faculty are employees of the EORTC and reported no Conflicts of Interest: Jan Bogaerts, Luc Boone, Corneel Coens, Catherine Fortpied, Michal Kicinski, Saskia Litière, Murielle Mauer, Jammbe Musoro, Coralie Poncet
*Travel expenses and hotel accommodation for the Invited Faculty will be refunded by the EORTC per request.
Clinical Trial Statistics for Non-Statisticians
10 – 13 June 2025, Brussels, Belgium
Course Registration Fees
Below rates include participation to the course from Wednesday 11 June until Friday 13 June.
An additional fee is applicable for participation in the Optional Introduction (half day) on Tuesday 10 June (see further down).
| Rate Academic / Not for Profit | Rate Pharma / For Profit | |
|---|---|---|
| Early Rate until 9 April 2025 |
840 EUR | 1 335 EUR |
| Late Rate until 28 May 2025 |
955 EUR | 1 505 EUR |
Optional Introduction – Extra Fee
| Optional Introduction on Tuesday 10 June 2025 | ||
|---|---|---|
| Rate Academic / Not for Profit | Rate Pharma / For Profit | |
| Early Rate until 9 April 2025 |
155 EUR | 245 EUR |
| Late Rate until 28 May 2025 |
180 EUR | 285 EUR |
Method of Payment
All payments are in Euro (€) and the full amount must be received by the corresponding deadline.
Accepted credit cards are: Mastercard or Visa.
To facilitate easy processing, please indicate your registration number in your remittance(s).
Bank transfers for registration should be made only to:
Bank name: BNP Paribas Fortis
Account holder: EORTC STATS /
BNP Education/Courses
IBAN: BE77 2100 5105 0142
SWIFT/BIC: GEBABEBB
PLEASE NOTE: Payments may take up to 24hrs to clear.
Cancellation Policy
Participants who need to cancel their registration are requested to inform the organiser by email.
In case of cancellation after 2 April 2025, an administrative fee of 30% fee will be retained from the participation fee and deducted from any refund. Refunds will be processed after the course.
In case of cancellation after 7 May 2025, or if no notice of cancellation is given, no refund will be paid.
For the full terms & conditions, click here.
New Regulations to Travel to Europe
The EU Entry/Exit System (EES) is due to start in 2025. It is a new electronic system implemented by the European Union to strengthen and streamline border management across the Schengen Area. It replaces the traditional passport stamping process with a digital system that records the entry and exit data of non-EU travellers. Further information can be consulted on this website.
The European Travel Information and Authorization System (ETIAS) is an entry requirement for visa-exempt nationals travelling to certain European countries, which is due to start 6 months after EES. Further information can be consulted on this website.
Clinical Trial Statistics for Non-Statisticians
10 – 13 June 2025, Brussels, Belgium
Venue
Address
DoubleTree by Hilton Brussels City
Rue Gineste 3
1210 Brussels
Belgium
Accommodation
Hotel bookings are not managed by EORTC.
A limited number of rooms have been reserved for this event at the course venue, at 215 EUR per night (10-11-12 June 2025). Rates are for single occupancy and include breakfast & VAT (excluding city tax). Accommodation can be booked via the button below.
Booking deadline for hotel reservations: 10 May 2025
Accommodation requests received after 10 May 2025 will be processed on a space-available basis and may be subject to higher rates. Individual guests will be responsible to reserve and guarantee their accommodation, and will be liable in case of cancellation, no show or early departure. The individual cancellation deadline is 72 hours prior to arrival. Cancellations and no-shows within 72 hours from arrival will be charged in full.
