SSCR
SAMPLE SIZE AND STATISTICS IN CLINICAL RESEARCH

Objectives :

Understand the methods and thinking for sample size justification of a clinical study and statistical analyses.

Level of trainees :

Any person involved in clinical research (CRA, Project Managers,…).

Duration and location :

  • Duration : 7 hours over 1 day
  • Location : Soladis training center in Paris or Lyon (to consult the calendar, click on “Sign up”) or directly in your office (minimum of 4 people)

Training fee :

  • In Soladis office : 700€ HT per trainee
  • Other : Please contact us for an offer adapted to your company.
Catherine

Pedagogical Manager : Catherine TUDAL

“This training is particularly adapted to people wishing to discover the world of biostatistics applied to clinical research and the role of the biostatistician in clinical research.”

Training Schedule

STATISTICAL REMINDERS

  • The statistical approach of a clinical study
  • Statistical parameters
  • The normal distribution
  • Confidence intervals

PRECISION OF DESCRIPTIVE PARAMETERS vs SAMPLE SIZE

  • Mean and standard deviation
  • Proportion
  • Correlation coefficient

CONSIDERATIONS PRIOR TO ENROLLMENT CALCULATIONS (OBSERVATIONAL OR INTERVENTIONAL STUDIES)

  • The most used clinical study designs: multi-arm and cross-over
  • The approach to enrollment calculation in a clinical study

Some exercises will be proposed in Excel in order to learn the concepts presented.

 

INTRODUCTION TO INFERENTIAL STATISTICS

  • Approach of a test
  • Alpha and beta risks
  • Power of a test

COMPARISON OF TWO GROUPS

  • Approach of the test
  • Calculation of the numbers / power

COMPARISON OF SEVERAL GROUPS

  • Approach of the ANOVA
  • Sample-size / power calculation
  • Opening on elaborated models

Use cases will be presented with Minitab, PAS or other software.

 

Do not hesitate to contact us for more information about this training, which can be organized in our training center (dates provided on our website) or directly in your premises, according to your preferences.

institute.soladis-blanc

Soladis - France (headquarter)
6-8 rue Bellecombe
69006 LYON - FRANCE
Tél: +33(0)4.72.83.86.70

Soladis GmbH - Switzerland
Lange Gasse 15
CH-4052 Basel
Phone: +41(0)58.258.15.80

Soladis Inc. - USA
185 Alewife Brook Pkwy, Unit 210
Cambridge, MA 02138-1100
Phone: (+1)857.675.1189

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