Short Overview
The program emphasizes the application of data analysis methods in randomized and non-randomized clinical trials. Introductory concepts of applied statistics, hypothesis testing, simple parametric and non-parametric techniques, multifactorial methods for the analysis of continuous data, and logistic regression will be taught. Special emphasis will be placed on the use of random effects models in the analysis of clinical trials.
Learning Goals
By the end of the program, participants should be able to perform at least basic data analysis from randomized or non-randomized clinical trials and draw conclusions from it.
- Goal "Introduction to Applied Statistics": Understanding concepts of applied statistics, the mechanism of hypothesis testing, and introducing the use of the SPSS statistical package.
- Goal "Hypothesis Testing Using the SPSS Package": Participants should be able to test for equality of value distributions in large or small clinical trials using the SPSS statistical package. They should also be able to determine the appropriate sample size for a trial.
- Goal "Multifactorial Analysis Models Using SPSS": Participants should be able to adjust a model for continuous data with one or more factors, select an optimal model, and interpret the results.
- Goal "Repeated Measures Analysis Using SPSS": Participants should be able to analyze their data in the presence of missing values, perform data analysis, and interpret the results when the data from a clinical trial is in the form of success-failure, such as in the case of adverse events during a trial. Finally, they should be able to conduct an analysis using mixed-effects models and interpret the results of data from a clinical trial that consists of at least two visits and measures a continuous variable, whether randomized or not.
Evaluation Method And Final Grade Computation
The evaluation is based on the preparation of exercises (every week) and a final assignment for each lesson, with real data, where the learner's knowledge will be evaluated. Successful completion of the program and award of a training certificate requires a final grade of at least 50%.
Learning Method Description
The program uses the eLearning educational method: learning takes place purely asynchronously (that is, on days and hours that serve the trainee, without mandatory attendance at a specific time or day), exclusively remotely (using a special educational platform via the internet from the trainee's area) and using digital educational tools that ensure effective and flexible individual self-learning. The program's training material becomes available at specific time periods, based on the training path followed, and then remains available on the training platform without restrictions throughout the duration of the program.