Statistics & Methodology Platform
Transforming Data into Insightful Results
A national network of expert statisticians supporting clinical research with advanced methods, tools, and training for better data analysis, visualisation, and reporting.
The Statistics & Methodology Platform has set three main objectives for 2025–2028, supported by several ambitious projects.
We invite you to contact us at stats@scto.ch if you would like to learn more.
Strengthen Statistical Quality and Compliance
We aim to enhance accuracy, reliability, reproducibility, and regulatory compliance in statistical practices through two major projects:
SCTO Computerised Systems Validation Policy for R
A comprehensive, risk-based approach to validate R software and ensure it meets regulatory standards is under development.
Key goals include:
- Establishing a common policy and framework for validating both the core R installation and add-on packages intended for use.
- Creating and maintaining a centralised inventory of all validated R packages within the SCTO Network, including tracking their validation status.
Promoting Reproducibility in Clinical Research
We strive to make research more reliable and transparent by:
- Reviewing reproducibility practices across the SCTO Statistics & Methodology Platform
- Creating practical tools for reproducible data analysis and reporting
- Partnering with key networks (Swiss Reproducibility Network, CRS Zurich, OSIRIS) to share resources, boost visibility, and advance reproducible methods
Advance Education and Training
We are committed to strengthening the expertise of statisticians within the SCTO Network and fostering a culture of continuous learning and knowledge sharing.
Practical Tutorials
We are developing and distributing accessible tutorials on key statistical methods and best practices. These tutorials are designed to support everyday challenges and serve as ongoing learning resources.
👉 Tutorials link →
Annual Workshop
The annual workshop highlights emerging statistical methods, keeping Network statisticians at the cutting edge of clinical research. In 2025, the workshop will focus on Bayesian Methods.
Expanding Collaborations
We aim to build and strengthen collaborations with leading research institutions.
Facilitate Data Analysis and Reporting
This objective is pursued through two complementary approaches:
New Statistical Tools & Programming Grant
We develop codes and programs to support data visualisation, analysis, and reporting, offering fresh solutions to persistent clinical research challenges.
This work is strengthened by our annual Programming Grant, which funds the creation of statistical tools that improve practice across the SCTO Network. Each grant (CHF 12,000) supports:
- Design, development, and testing of tools
- Cross-checking with another CTU to ensure usability
The programme fosters collaboration and builds a sustainable repository of shared resources.
Promoting Standardised Data Practices
We advocate for the adoption of standardised data formats (e.g., CDISC-compliant eCRFs, AdaM datasets) to improve quality, transparency, and consistency across studies. This work is conducted in close collaboration with the Data Management Platform.
All tools are also searchable in the SCTO Tools & Resources Navigator at the top of this page.
Data Sharing Guidance
Sharing of Data from Clinical Research Projects: Guidance from the SCTO CRC Network
This guidance document provides practical recommendations for sharing data from clinical research projects in line with Swiss legislation. It helps researchers navigate ethical, legal, and procedural challenges in sharing clinical data, and promotes transparency, reproducibility, and collaborative research.
🔗Sharing of Data – SCTO Guidance
Statisticians in Independent Data Safety Monitoring Boards
SCTO Statisticians in Independent Data Monitoring Committees of Academic Studies (IDMCs)
This position paper clarifies the role and expectations of statisticians from the SCTO Network serving on IDMCs. It defines independence, responsibilities, and collaboration models to maintain trust and scientific rigour in safety oversight during trials.
Development of Statistical Tools
Over recent years, numerous statistical tools, R-packages, and guidance documents have been developed to support analysis and daily work in clinical trials and observational studies. These are publicly available and are listed below.
harmBounds
Authored by: Lukas Butikofer, DCR Bern
Published in December 2025
harmBounds R Package calculates stopping probabilities, defines stopping boundaries, and produces plots for safety monitoring using a simple event-based approach. The package supports safety interim analyses during trial conduct. Further development toward a broader vignette on safety interim analyses is being considered.
Statistical Analysis Plan (SAP) for Observational Studies
Authored by: Ainesh Sewak, Mireille Moser, Cyril Jaksic and Lukas Bütikofer
Published in November 2025
Researchers conducting observational studies have been increasingly encouraged to develop and use Statistical Analysis Plans (SAPs). The SAP template offers structured guidelines for prespecifying important aspects of the statistical analysis. These include study objectives, study design, expected biases, eligibility criteria, outcomes, covariates and analytical methods. While all sections in the template are recommended, even completing a simplified version early in the study process can help strengthen study integrity and reduce post hoc changes or analysis. The aim of prespecifying the statistical analysis is to avoid questionable research practices such as p-hacking or data dredging. The template supports more trustworthy and reproducible findings in observational research.
Statistical Analysis Plan (SAP) for Observational Studies
randotools package
Authored by: Alan G Haynes
Published in November 2025
randotools simplifies the creation of randomisation lists, a crucial element of randomised clinical trials. The package streamlines both the generation and management of these lists, making the process simple and efficient.
SummarySCI
Authored by: Sämi Schär & Charlotte Micheloud
Published in October 2025
An R Package that produces Publication-Ready Summary Tables with descriptive statistics for continuous, categorical and dichotomous variables. Largely based on the package ‘gtsummary’; Sjoberg DD et al. (2021) <doi:10.32614/RJ-2021-053>, it offers a seamless integration with Quarto, with particular emphasis on producing well-formatted Word outputs.
Package on CRAN
survSAKK
Authored by: Charlotte Micheloud, Swiss Cancer Institute
Published in September 2025
The survSAKK R package provides the surv.plot() function, facilitating Kaplan-Meier survival analysis. Designed with user-friendliness and efficiency in mind. Offering a robust tool for analysing survival data. It utilises the functionalities of survival::survfit().
An R package providing functions to facilitate Kaplan–Meier survival analysis. And produce publication-ready Kaplan- Meier plots.
GitHub package
CRAN package
powerGrid
Authored by: Dr Gilles Dutilh & Richard Charles Allen
Published in September 2025
This tool evaluates a user-defined function across different parameter combinations. Given a required trial power (or other design objective such as confidence interval width) and assumptions about the trial population, it assists in estimating the required design parameters (most commonly the required sample size). Calculation of the trial design objective can be simulated, with optional parallel computing for faster performance. Built-in visualisation tools illustrate how trial design varies under different parameter assumptions, facilitating efficient study planning and decision-making.
Package on CRAN
SecuTrialR
Authored by: Alan G. Haynes, Patrick R. Wright, Milica Markovic, Gilles Dutilh, Armando Lenz, Pascal Benkert, Silvia Grieder, Pia Neuschwander & Constantin Sluka
Published in May 2024
An R package to import and manage secuTrial CDMS datasets in R. Designed to simplify repetitive data handling tasks and allow more focus on specific project needs.
CRAN package
presize
Authored by: Armando Lenz, Alan G. Haynes, Andreas Limacher, Odile Stalder, Marie Roumet
Published in February 2023
An R-package providing functions for precision-based sample size calculations.
Scientific publication: JOSS paper SCTO_SAF_presize_R-package
Technical tools:
Shiny calculator
GitHub package page
CRAN package page
selcorr
Authored by: Marco Cattaneo
Published in December 2021
An R-package calculating post-selection confidence intervals and p-values for the coefficients of (Generalised) Linear Models.
CRAN package page
sts_graph_landmark
A Stata package to create Landmark analysis Kaplan-Meier curves, completed with risk tables.
GitHub repository
RedCapTools
An R package for exporting data from REDCap and preparing them for analysis using just a few lines of code.
GitHub package page
secuTrialR
An R package to import and manage secuTrial CDMS datasets in R. Designed to simplify repetitive data handling tasks and allow more focus on specific project needs.
CRAN package page
survSAKK
An R package providing functions to facilitate Kaplan–Meier survival analysis. And produce publication-ready Kaplan- Meier plots.
GitHub package page
CRAN package page
Dedicated websites and Platforms for Statisticians
The Statistics & Methodology Platform has developed multiple resources to support agile development, collaboration, and sharing of statistical tools, codes, tutorials, and training materials.
Dedicated Website for Statisticians
A dedicated website compiles guidelines, tutorials, courses, and statistical packages developed by the SCTO network. This resource allows agile updates and gives access to tools and expert advice from statisticians within the Statistics & Methodology Platform.
🔗 Visit the Stats Platform site
Vignettes – Practical Tutorials for Statisticians
This section offers hands-on, accessible tutorials covering a variety of statistical topics. Designed to support the training of researchers and statisticians, these vignettes target diverse user groups depending on content.
Statistics and Methodology Platform GitHub
The SCTO’s GitHub repository hosts all statistical code developed by the Statistics & Methodology Platform. It is a collaborative space for sharing, storing, and maintaining validated tools and R packages.
Workshop in Statistics
An annual workshop is organised by the STAT & METH Platform to strengthen expertise and drive innovation across the SCTO Network. These workshops provide members with in-depth exposure to new tools, trends, and solutions in statistics and methodology for clinical research.
| Workshop history: | |
| 2019 | Competing Risk Modelling |
| 2020 | Estimands and Causal Inference |
| 2021 | Joint Modelling of Longitudinal and Survival Data |
| 2022 | Non-linear Models |
| 2023 | Machine Learning for Statisticians |
| 2024 | Advanced Clinical Trial Designs |
Meet the Platform Team
Meet the individuals whose expertise and collaboration drive each Platform forward. Together, they help strengthen clinical research across Switzerland through shared knowledge, leadership, and innovation.
Team Members
Iulia-Maia Muresan – Coordinator, DCR Bern
Marie Roumet – Coordinator, DCR Bern
Lukas Butikofer – Member, DCR Bern
Alan Haynes – Contributor, DCR Bern
Sylvain Pierre Losdat – Contributor, DCR Bern
Ainesh Sewak – Contributor, DCR Bern
Veronika Whitesell – Contributor, DCR Bern
Andre Moser – Contributor, DCR Bern
Odile Stalder – Contributor, DCR Bern
Dierik Hans Heg – Contributor, DCR Bern
Jean-Benoit Rossel – Contributor, DCR Bern
Michael Coslovsky – Member, DKF Basel
Deborah Vogt – Contributor, DKF Basel
Valentin Klotzbücher – Contributor, DKF Basel
Andrea Wiencierz – Contributor, DKF Basel
Sabine Schaedelin – Contributor, DKF Basel
Laura Werlen – Contributor, DKF Basel
Pia Neuenschwander – Contributor, DKF Basel
Nikki Rommers – Contributor, DKF Basel
Lisa Hofer – Contributor, DKF Basel
Richard Allen – Contributor, DKF Basel
Marco Cattaneo – Contributor, DKF Basel
Stephan Benke-Bruderer – Member, CTC Zürich
Stefanie von Felten – Contributor, CTC Zürich
Monika Hebeisen – Contributor, CTC Zürich
Ulrike Held – Contributor, CTC Zürich
Christophe Combescure – Member, CRC Geneva
Cyril Mirko Jaksic – Contributor, CRC Geneva
Antoine Poncet – Contributor, CRC Geneva
Clelia Di Serio – Member, CTU-EOC Lugano
Lorenzo Ruinelli – Contributor, CTU-EOC Lugano
Luca Clivio – Contributor, CTU-EOC Lugano
Alberto Pagnamento – Contributor, CTU-EOC Lugano
Mireille Moser – Member, CRC Lausanne
Julien Sauser – Contributor, CRC Lausanne
Erin West – Member, CTU HOCH St.Gallen
Jakob Heimer – Contributor, CTU HOCH St.Gallen
Verena Gotta, Voluntary Contributor, SwissPedNet
Andreas Limacher – Voluntary Contributor, Schweizer Paraplegiker-Zentrum
Jérôme Pasquier – Voluntary Contributor, ETHZ /nexus
Michael Prummer – Voluntary Contributor, ETHZ /nexus
Charlotte Micheloud – Voluntary Contributor, Swiss Cancer Institute
Tudor Jumuga – Voluntary Contributor, Swiss Cancer Institute
Stefanie Hayoz – Voluntary Contributor, Swiss Cancer Institute
Saemi Schaer– Voluntary Contributor, Swiss Cancer Institute
Elio Carreras – Voluntary Contributor, Swiss Cancer Institute
Laurence Chapatte – Scientific Affairs Manager & Liaison Officer, SCTO
Iulia-Maia Muresan
Coordinator, DCR Bern
Marie Roumet
Coordinator, DCR Bern
Stephan Benke-Bruderer
Member, CTC Zürich
Lukas Butikofer
Member, DCR Bern
Christophe Combescure
Member, CRC Geneva
Michael Coslovsky
Member, DKF Basel
Clelia Di Serio
Member, CTU-EOC Lugano
Mireille Moser
Member, CRC Lausanne
Erin West
Member, CTU HOCH St.Gallen
Laurence Chapatte
Scientific Affairs Manager & Liaison Officer
Other Platform Contributors
Team Members
Richard Allen – Contributor, DKF Basel
Elio Carreras – Voluntary Contributor, Swiss Cancer Institute
Marco Cattaneo – Contributor, DKF Basel
Luca Clivio – Contributor, CTU-EOC Lugano
Verena Gotta, Voluntary Contributor, SwissPedNet
Alan Haynes – Contributor, DCR Bern
Stefanie Hayoz – Voluntary Contributor, Swiss Cancer Institute
Monika Hebeisen – Contributor, UZH
Dierik Hans Heg – Contributor, DCR Bern
Jakob Heimer – Contributor, CTU HOCH St.Gallen
Ulrike Held – Contributor, UZH
Lisa Hofer – Contributor, DKF Basel
Cyril Mirko Jaksic – Contributor, CRC Geneva
Tudor Jumuga – Voluntary Contributor, Swiss Cancer Institute
Valentin Klotzbücher – Contributor, DKF Basel
Andreas Limacher – Voluntary Contributor, Schweizer Paraplegiker-Zentrum
Sylvain Pierre Losdat – Contributor, DCR Bern
Charlotte Micheloud – Voluntary Contributor, Swiss Cancer Institute
Andre Moser – Contributor, DCR Bern
Pia Neuenschwander – Contributor, DKF Basel
Alberto Pagnamento – Contributor, CTU-EOC Lugano
Jérôme Pasquier – Voluntary Contributor, ETHZ /nexus
Antoine Poncet – Contributor, CRC Geneva
Michael Prummer – Voluntary Contributor, ETHZ /nexus
Nikki Rommers – Contributor, DKF Basel
Jean-Benoit Rossel – Contributor, DCR Bern
Lorenzo Ruinelli – Contributor, CTU-EOC Lugano
Julien Sauser – Contributor, CRC Lausanne
Sabine Schaedelin – Contributor, DKF Basel
Saemi Schaer– Voluntary Contributor, Swiss Cancer Institute
Ainesh Sewak – Contributor, DCR Bern
Constantin Sluka – Contributor, DKF Basel
Odile Stalder – Contributor, DCR Bern
Deborah Vogt – Contributor, DKF Basel
Stefanie von Felten – Contributor, UZH
Laura Werlen – Contributor, DKF Basel
Veronika Whitesell – Contributor, DCR Bern
Andrea Wiencierz – Contributor, DCR Bern