Introduction
Programme
Faculty
Accreditation
Registration
Venue
Clinical Trial Statistics
for Non-Statisticians
11 – 14 June 2024, 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
11 – 14 June 2024, 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 11 June 2024
Optional introduction to probability and statistics
Wednesday 12 June 2024
Principles of comparative clinical trials
Thursday 13 June 2024
Advanced methods for phase III trials
Friday 14 June 2024
Exploratory studies and adaptive designs
The detailed programme can be consulted below.
Tuesday 11 June 2024
| 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 12 June 2024
| 08.30 |
Discussion of homework from Tuesday
Luc Boone
|
| 08.50 | End of Optional Introduction |
Principles of comparative clinical trials
Chair: Saskia Litière
| 08.00 | Registration and welcome coffee |
| 09.00 |
Welcome and introduction
Saskia Litière
|
| 09.15 |
General statistical principles
Coralie Poncet
|
| 10.15 |
Statistical analysis of time to event endpoints (I)
Marta Fiocco
|
| 10.45 | Coffee break |
| 11.05 |
Statistical analysis of time to event endpoints (II)
Marta Fiocco
|
| 11.35 |
Trial endpoints and design of phase III trials
Saskia Litière
|
| 12.35 | Lunch |
| 13.30 |
Sample size for phase III trials
Stefan Michiels
|
| 14.30 |
Problems and pitfalls of data analysis and interpreting results (I)
Murielle Mauer
|
| 15.00 | Coffee break |
| 15.20 |
Problems and pitfalls of data analysis and interpreting results (II)
Murielle Mauer
|
| 15.50 |
Quiz
Moderator: Saskia Litière
|
| 16.30 | Networking reception |
| 18.00 | End day 1 |
Advanced methods for Phase III trials
Chair: Murielle Mauer
| 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: Gareth Griffiths
|
| 11.10 |
Stat Clinic II
IDMC: What would you recommend?
G. Griffiths / X. Paoletti, S. Litière / M. Kicinski, J. Bogaerts / M. Mauer, C. Coens / R. Porcher
|
| 12.10 |
Wrap up of Stat Clinic II (IDMC)
Moderator: Gareth Griffiths
|
| 12.30 | Lunch |
Exploratory studies
Chair: Murielle Mauer
| 13.30 |
Design and analysis of phase I studies
Xavier Paoletti
|
| 14.20 |
Phase II designs without biomarkers
Jammbe Musoro
|
| 15.10 | Coffee break |
| 15.30 |
Biomarker based study designs
Raphaël Porcher
|
| 16.20 |
Quiz
Moderator: Murielle Mauer
|
| 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 |
Quality of life
Corneel Coens
|
| 10.30 | Coffee break |
| 10.50 |
Adaptive trials
Christina Yap
|
| 11.50 |
Systematic reviews and meta-analyses
Steven MacLennan
|
| 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
Saskia Litière
|
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.
Clinical Trial Statistics for Non-Statisticians
11 – 14 June 2024, Brussels, Belgium
Faculty
EORTC Headquarters Brussels, Belgium
Murielle Mauer - Co-Chair
Lead Statistician, 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.
EORTC Headquarters Brussels, Belgium
Saskia Litière - Chair
Head of Statistics Department, 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. She worked on projects related to breast cancer, sarcoma, endocrine tumors, and malignancies of the genito-urinary tract.
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).
Université de Versailles
St Quentin & Institut Curie, France
Xavier Paoletti - Co-Chair
Professor of Biostatistics, Université de Versailles – St Quentin (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 U900 research unit dedicated to the development of statistical methods for clinical trials integrating biomarkers.
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 pediatric oncology trials, the design of trials evaluating personalized medicine and the validation of surrogate endpoints. He co-coordinates the GASTRIC collaboration for performing meta-analyses in gastric cancers and he coordinates the gynecology cancer inter group (GCIG) meta-analysis with Dr Ros Glasspool for performing meta-analyses in ovarian cancer. He is a member of the Curie institutional Ethics Committee.
Speakers
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.
Corneel Coens
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 Gynaecological Cancer Group since 2001. 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”.
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 - Speaker
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.
Steven MacLennan
Research Fellow,Academic Urology Unit, University of Aberdeen
Aberdeen, United Kingdom
My research involves clinical trials, as well systematically reviewing, critically appraising and synthesising intervention effectiveness data, and incorporating these forms of evidence in clinical practice guideline (CPG) recommendations using transparent evidence-to-decision methods. I also apply mixed methods in developing core outcome sets, and in consensus projects to assist CPG panels to give interim guidance in the face of no evidence, low quality evidence or conflicting evidence.
Another arm of my research is directed toward addressing evidence gaps whereby interventions underpinned by high quality evidence and strong recommendations in CPGs are not routinely followed – this again requires a mixed methods approach to investigate practice patterns, barriers and facilitators to practice, and developing knowledge transfer interventions. I am a member of the European Association of Urology’s (EAU) methodology committee which oversees and delivers the EAU’s systematic review and CPG development training programmes, and a founding member of the EAU’s IMAGINE group, which aims to tackle evidence-to-practice gaps in urology.
Stefan Michiels
Director Oncostat Team CESP, INSERM U1018, Department of Biostatistics and Epidemiology, Institut Gustave Roussy
Villejuif, France
Stefan Michiels is Head of the Office of Biostatistics and Epidemiology at Gustave Roussy, and Head of Oncostat, CESP, INSERM U1018, University Paris-Saclay in Villejuif, France. His areas of expertise are clinical trials, meta-analyses, biomarkers and clinical prediction models. Stefan is the currently the chair of the biostatisticians at Unicancer, a French collaborative cancer clinical trials group.
Stefan holds a PhD in Biostatistics from the School of Public Health at the University Paris-Sud and Master Degrees in Statistics and in Applied Mathematics from the University of Leuven. His previous positions include the Université Libre de Bruxelles- Institut Jules Bordet (Belgium), the National Cancer Institute (France) and the University of Leuven (Belgium). Stefan has edited with Susan Halabi the book “Textbook of Clinical Trials in Oncology – A Statistical Perspective“ and has authored above 200 peer-reviewed publications (http://www.publicationslist.org/stefan.michiels). He is currently member of the editorial board of Annals of Oncology, NPJ Breast Cancer and Cancer Prevention Research and performs regular statistical reviews for the Lancet family of journals.
Jammbe Musoro
Senior Statistician, Statistics Department, EORTC Headquarters
Brussels, Belgium
Jammbe obtained a PhD in Biostatistics at the Academic Medical Center, University of Amsterdam in 2016. He joined the EORTC headquarter in October 2015 as a quality of life research fellow. Jammbe is involved in several research projects and leads the EORTC Minimally important difference (MID) project that aims to provide interpretational guidelines for the EORTC QLQ-C30 in cancer clinical trials. He is also the designated statistician for the EORTC cutaneous lymphoma tumor group, where he provides statistical support in the design of cancer clinical trials.
Coralie Poncet
Senior Statistician, Statistics Department, EORTC Headquarters
Brussels, Belgium
Coralie Poncet obtained 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, as a senior statistician, providing support for the design and analysis of clinical trials of the breast Cancer Group.
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 - Speaker
Professor of Clinical Trials Biostatistics, The Institute of Cancer Research
London, United Kingdom
Christina Yap is Professor of Clinical Trials Biostatistics and Team Leader of ICR-CTSU Early Phase & Adaptive Trials at the Institute of Cancer Research. Christina has over 20 years of experience in statistical design and analysis of clinical trials. Her main expertise comprises of development and practical implementation of efficient design and analysis in clinical trials. This includes adaptive designs in early phase dose-finding trials as well as multi-arm multi-stage randomised Phase II/III designs and platform designs; including Bayesian approaches to such settings. She is a Joint-lead of the Precision Medicine Working Group within the MRC-NIHR Trials Methodology Research Partnership (TMRP) and chair its rare disease subgroup; co-lead of the NIHR Statistics Group – Early Phase Trials, core committee member of TMRP Statistical Analysis Working Group and member of the TMRP Adaptive Designs Working Group. She sits on funding panels, including Cancer Research UK Clinical Research Committee and the French National Cancer Institute evaluation committee for early phase clinical trials on innovative drugs. She is an expert advisor on the MHRA Clinical Trials, Biologicals and Vaccines Expert Advisory Group. She is the Principal Investigator for the international consensus-based SPIRIT and CONSORT extensions for dose-finding trials.
Clinical Trial Statistics for Non-Statisticians
11 – 14 June 2024, 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 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.
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.
Clinical Trial Statistics for Non-Statisticians
11 – 14 June 2024, Brussels, Belgium
Course Registration Fees
| Rate Academic / Not for Profit | Rate Pharma / For Profit | |
|---|---|---|
| Early Rate until 10 April 2024 |
840 EUR | 1 335 EUR |
| Late Rate until 29 May 2024 |
955 EUR | 1 505 EUR |
Optional Extra
| Optional Introduction to probability and statistics | ||
|---|---|---|
| Tuesday 11 June 2024 (afternoon) |
Rate Academic / Not for Profit | Rate Pharma / For Profit |
| Early Rate until 10 April 2024 |
155 EUR | 245 EUR |
| Late Rate until 29 May 2024 |
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.
Cheques and bank drafts are NOT accepted.
Cancellation Policy
Participants who need to cancel their registration are requested to inform the organiser by email.
In case of cancellation after 3 April 2024, an administrative fee of 30% fee will be retained from the participation fee and deducted from any refund. Refunds will be processed by bank transfer after the course.
In case of cancellation after 8 May 2024, or if no notice of cancellation is given, no refund will be paid.
For the full terms & conditions, click here
Clinical Trial Statistics for Non-Statisticians
11 – 14 June 2024, Brussels, Belgium
Venue
Address
The Hotel.Brussels
38 Boulevard de Waterloo
1000 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 275 EUR per night (11 and 12 June 2024) / 230 EUR per night (13 June 2024). 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: 11 May 2024
Accommodation requests received after 11 May 2024 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. Any cancellations after this time are subject to one night’s rate and tax. No-show or early departure will be charged at full rate and for the entire length of stay.
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