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Statistical study of vaccine development Print E-mail

Statistical expertise on clinical study trials in a new meningococcal vaccines development



 

Activity and interventions

  • Participation in setting up a study, performing statistical analysis and reporting the results.
  • Specific programming using SAS.
  • Integrated Safety Summaries and IDMC.


Technical environment

 

 
  • Windows
  • SAS

 


Key figures

 

  • Project duration: 3 years (ongoing)

Context

 

Vaccination is one of the most cost-effective and successful public health interventions. It has been used to tackle diseases such as rabies, diphtheria, tetanus, yellow fever, polio, measles, mumps, rubella and hepatitis B.

 

Before vaccines and medications come on the market, they have to be tested in clinical trials.

The objective of this project is to participate in the statistical aspects of the meningococcal vaccine clinical development.

 

 

 

ALTEN's achievements

 

The following tasks were performed:

  • Participation in protocol writing, CRF review.
  • Data cleaning: check elimination codes and review of cleaning report.
  • Study reporting and Analysis Plan.
  • Statistical analysis and results reports.
  • Clinical Study Reports and Publications review.
  • Programming in SAS: study specific macros.
  • Performing Integrated safety summaries.
  • Independent statistician for IDMC.

 

 

 

ALTEN's Added value

 

  • Flexibility and high reactivity on different tasks.
  • Good communication with the team.
  • Efficiency and good organizational skills.
  • Statistical expertise.