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 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)

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.

References

ICH GCP E6(R2) – see in particular guideline

• 6.9 Statistics