Introduction

Programme

Faculty

Registration

Venue

Clinical Trial Statistics
for Non-Statisticians

11 – 14 June 2024, Brussels, Belgium

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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

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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)
Yassin Pretzenbacher
15.20 Coffee break
15.40
Introduction to statistical methods (Part II)
Yassin Pretzenbacher
17.00 End day 1 of Optional Introduction

Wednesday 12 June 2024

08.30
Discussion of homework from Tuesday
Yassin Pretzenbacher
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)
Matthew Sydes
10.30 Coffee break
10.50
Introduction to Stat Clinic II (IDMC)
Moderator: Matthew Sydes
11.10
Stat Clinic II
IDMC: What would you recommend?
M. Sydes / X. Paoletti, S. Litière / M. Kicinski, J. Bogaerts / R. Porcher, C. Coens / M. Mauer
12.10
Wrap up of Stat Clinic II (IDMC)
Moderator: Matthew Sydes
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
Matthew Sydes
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
  • To estimand or not to estimand: a practical
    Corneel Coens – Murielle Mauer
  • More about non-inferiority
    Catherine Fortpied
  • Design of a biomarker-based study practical
    Christina Yap – Xavier Paoletti
  • Sample size calculation practical
    Michal Kicinski – Saskia Litière
15.00 Coffee break
15.20 Stat Clinic V

Parallel workshops on selected topics
  • To estimand or not to estimand: a practical
    Corneel Coens – Murielle Mauer
  • More about non-inferiority
    Catherine Fortpied
  • Design of a biomarker-based study practical
    Christina Yap – Xavier Paoletti
  • Sample size calculation practical
    Michal Kicinski – Saskia Litière
16.20
Views towards the future
Jan Bogaerts
16.50
Closing remarks
Saskia Litière

An application has been made to the UEMS-EACCME® for CME accreditation of the ‘Clinical Trial Statistics for Non-Statisticians’ course.

Clinical Trial Statistics for Non-Statisticians

11 – 14 June 2024, Brussels, Belgium

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Faculty

Murielle Mauer
Murielle MauerCo-Chair
Lead Statistician
EORTC Headquarters Brussels, Belgium
Saskia Litière
Saskia LitièreChair
Head of Statistics
EORTC Headquarters Brussels, Belgium
Xavier Paoletti
Xavier Paoletti Co-Chair
Professor of Biostatistics
Université de Versailles
St Quentin & Institut Curie, France

Speakers

Jan Bogaerts
Jan Bogaerts
Corneel Coens
Corneel Coens
Marta Fiocco
Marta Fiocco
Catherine Fortpied
Catherine Fortpied
Michal Kicinski
Michal Kicinski
Steven MacLennan
Steven MacLennan
Stefan Michiels
Stefan Michiels
Jammbe Musoro
Jammbe Musoro
Coralie Poncet
Coralie Poncet
Raphaël Porcher
Raphaël Porcher
Yassin Pretzenbacher
Yassin Pretzenbacher
Matthew Sydes
Matthew Sydes
Christina Yap
Christina Yap

Clinical Trial Statistics for Non-Statisticians

11 – 14 June 2024, Brussels, Belgium

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European Accreditation

An application has been made to the UEMS-EACCME® for CME accreditation for the ‘Clinical Trial Statistics for Non Statisticians’.

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

U.E.M.S. Accreditation

Clinical Trial Statistics for Non-Statisticians

11 – 14 June 2024, Brussels, Belgium

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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

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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.

Next events

  • 6th EORTC Quality of Life in Cancer Clinical Trials Conference

    Barcelona, Spain

  • 36th EORTC-NCI-AACR Symposium

    Barcelona, Spain

  • 24th Workshop on Methods in Clinical Cancer Research (MCCR)

    Sint Michielgestel, Netherlands

  • Clinical Trial Statistics for Non-Statisticians

    Brussels, BE