Your Easy Guide to Clinical Studies

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 randomisation list to be implemented in the study
• Write the statistical section of the study protocol
• Perform the statistical analysis of the study and write the statistical study report
• Support the SP-INV in interpreting statistical information in order for the SP-INV to draw conclusions and make predictions

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.

 

For more information refer to Statistics in this Study Guide.

References

ICH GCP E6(R2) – see in particular guideline

• 6.9 Statistics