What is it? Why is it important?

The statistician works in collaboration with the SP-INV to decide on a suitable study design able to answer the research question.

 

Responsibilities of the statistician include to:

  • Write and/or review the statistical sections of the study protocol
  • Determine the required sample size based on information communicated by the SP-INV
  • Write and/or review the Statistical Analysis Plan (SAP)
  • Generate the randomisation list to be implemented in the study
  • Perform the statistical analysis of the study (e.g. interim- and final analysis)
  • Report and interpret the results of the statistical analysis (e.g. scientific publications)

What do I need to do?

As a SP-INV, establish a requirement profile for a statistician. A qualified statistician can help you to answer important questions such as:

  • Can the study hypotheses be answered statistically?
  • Are the selected study endpoints able to answer the study question?
  • Based on study design what sample size would be required to ensure statistical power?
  • What statistical analysis plan would best-fit-for-purpose
  • Based on required sample size, is the access to local participants adequate or is an expansion to a multi-centre study required?

 

Based on your research question, the statistician will be able to suggest the most appropriate study design and statistical method(s) needed to provide a useful answer.

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guideline

  • 6.9 Statistics
Abbreviations
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • SAP – Statistical Analysis Plan
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Management ↦ Stakeholders ↦ Statistician
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 Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Concept ↦ Data Management ↦ Stakeholders ↦ Statistician

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