Your Easy Guide to Clinical Studies

A statistician uses statistics with the aim to help researchers in the interpretation of their data.

 

Tasks may include support:

• Prior to study start:
  • Calculate the number of study participants needed to answer the primary research question (e.g. sample size calculation)
  • Assist in the writing of the study protocol (e.g. planned interim analysis, definition of statistical method(s))
  • Program the randomization list (e.g. participants are randomly allocated either to an intervention or control group)

 

• After data collection:
  • Validate the data to ensure there are no obvious mistakes (e.g. dates = 2032, unrealistic vital signs such as body temperature = 85°C)
  • Prepare the data for analysis (e.g. derive new variables, such as BMI calculations based on weight and height)
  • Analyse the data (e.g. based on specifications given in a study protocol)
  • Present the statistical results by writing a statistical report
  • Assist in the publication of the study (e.g. scientific publications, abstract, posters)

As a SP-INV request the assistance of a statistician as early as possible (e.g. during the concept phase of your study).

 

A statistician can:

• Assist in study planning, such as the selection of an appropriate study design, set-up of the study’s randomisation procedures, select the appropriate statistical methods
• Assist in writing the statistical section of the study protocol
• Perform the statistical analysis during study conduct (e.g. interim analysis) and upon study termination
• Write the statistical report
• Assist in the presentation of study results (e.g. publications, posters)

 

As a SP-INV, ensure the study statistician has the appropriate education and training needed to manage the statistical aspects of your study. 

 

Typically, a statistician has no education in medicine. Good communication and a close collaboration is therefore the key to success.

References

ICH Topic E9 statistical Principles for Clinical Trials – see in particular

• 1.1. Background and Purpose