What is it? Why is it important?

Based on the Swiss law (e.g. HRA) and the necessity for research transparency, requires that research results are published.

 

The statistician supports and is involved in the publication of study results. Responsibilities include to:

  • Write a statistical report. The report summarizes the statistical analyses used to analyse the study data, and provides a presentation of study results (e.g. tables, graphs, pictures)
  • Assist in the writing of scientific publications (e.g. poster presentations, publications in scientific journals)
  • Update and present study results on recognized platforms (e.g. KOFAM, ClinicalTrials.gov, WHO, EudraCT)

 

The statistician must ensure that publications are statistically sound, results are accurately interpreted, and that research findings are presented in a clear and objective manner

What do I need to do?

As a SP-INV:

  • Ensure the statistician provides you with a statistical report, and that the interpretation of results are scientifically correct and presented in a clear and convincing manner
  • Consult and involve a statistician when writing and reviewing your scientific publications. Prior to publication, a scientific paper is initially subjected to a peer review of experts. The publication can only be published after all reviewers have approved the document.
  • Ensure results are registered on study registered platforms

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

For study registration access:

 

Swiss Law

HRA – see in particular article

  • Art. 56 paragraph 3b Publication of results
Abbreviations
  • CTU – Clinical Trials Unit
  • EudraCT – European Union Drug Regulating Authorities Clinical Trials Database
  • HRA – Human Research Act
  • KOFAM – Coordination Portal for Human Research
  • SP-INV – Sponsor-Investigator
  • WHO – World Health Organization
Completion ↦ Statistic Methodology ↦ Publication ↦ Statistician Responsibility
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Completion ↦ Statistic Methodology ↦ Publication ↦ Statistician Responsibility

Please note: the Easy-GCS tool is currently under construction.