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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 6.9 Statistics