Basic↦Statistics↦Statistics↦Statistician Role
Was betrifft es? Warum ist das wichtig?
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)
Was muss ich befolgen?
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.
Wo kann ich Hilfe anfordern?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
References
ICH Topic E9 statistical Principles for Clinical Trials – see in particular
- 1.1. Background and Purpose