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 study question.

Responsibilities include to:

  • Write the Statistical Analysis Plan (SAP), which includes to define
    • Required sample size
    • Outcome measures
    • Applicable statistical methods
    • Requirement for interim analysis
    • Randomisation procedures
    • Format and frequency of data exports
  • Elaborate the list of randomisation to be implemented in the study
  • Write the statistical section of the study protocol
  • Perform the statistical analysis of the study (e.g. description of results)
  • Support the SP-INV in interpreting statistical information in order for the SP-INV to draw conclusions and make predictions

What do I need to do?

Select or hire a qualified statistician who can help you:

  • 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?
  • Select a study design able to provide you with relevant data able to answer the study question

For more information refer to Statistics in this Study Guide.

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
  • SAP – Statistical Analysis Plan
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Stakeholders ↦ Statistician
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Data Handling ↦ Stakeholders ↦ Statistician

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