F1 › Biostatistics and clinical trial methodology - Critical reading of articles Understand the best practices and methods of biostatistics applied to randomized clinical trials.

Goals

Acknowledge a comprehensive but accurate understanding of the clinical trial’s methodology

Know the key issues and possible solutions during statistical analysis

Know how to evaluate quickly the methodological quality of a published article concerning the results of a clinical trial

Description

Profile of trainees

Health professionals: physicians, ARCS, pharmacists, researchers, medical representatives. Two-year diploma - The syllabus can be adapted to the needs of biostatistician

Pre-requisites

None

Duration

1 day / 7 hours

Price

Inter 600 € HT per trainee - at least 3 trainees Intra Contact us for a service that works best for your business

Location

Inter In Lyon or Paris Intra On site

Program

Overview : Data-Management et Biostatistiques

• • Review of the biometric process (clinical data circuit) and introduction of technical vocabulary, abbreviations etc.
• • Review of the contents of the major documents CRF, Blind-review report, SAP.
• • Presentation of the various reference documents (ICHE9, ICHE10, EMA Guidelines)
• • Review of the action plan of a drug (pre-clinical to the AMM)

Summary on statistical concepts

• • The statistical approach
• • Descriptive statistics
• • Inferential statistics (statistical tests, risks, power, sample size)
• • Application and condition of use of the main tests and analytical models (t-test, Chi 2, ANOVA, logistic regression, survival analysis)
• • Best Practices in Statistics

Discussion of key methodological points

• • Populations (ITT, FAS, PP, Safety ...)
• • Superiority Test, Non-Inferiority Test
• • Alpha risk, power of a study (assumptions and calculation of sample size, case study on samples or examples from trainees)