Short Overview
The program aims to provide an introduction to the design of clinical trials and their analysis using the R language. The design will encompass types of measurements, types of designs for clinical studies, sample size determination using R, randomization procedures with R, determination of power, and interim analyses. The analysis includes specifying the population for analysis, charts, basic analyses, but also an introduction to more complex ones such as survival analysis, multiple regression, and logistic regression, as well as an introduction to concepts like subgroup analysis and interaction.
Learning Goals
By following the program, participants should be able to distinguish the basic designs of a clinical trial, determine the appropriate sample size, implement different randomization schemes, and conduct the analysis of a clinical trial.
- Introduction to the R language: The goal is to introduce the tools of the R language that will be useful for understanding the subsequent lessons.
- Designs of clinical trials: The objective is to learn the structure of a clinical trial and understand different designs that can achieve research questions. A specific goal is to achieve randomization of a trial using the R language.
- Introduction to power and sample size: The goal is for participants to be able to propose the appropriate sample size for not particularly complex clinical trials.
- Analysis of clinical trial data: Upon completion of the course, participants should be able to perform simple analyses on a wide range of clinical trials based on the types of endpoints.
Program Value
By attending the program, participants should be able to distinguish the basic designs of a clinical trial, determine the appropriate sample size, implement simple randomization, and conduct a basic analysis of a clinical trial.
Teaching Material
- Slides
- Notes
- Bibliography
- Exercises (applications of data analysis under different types of clinical trials)
- Assignments
Evaluation Method And Final Grade Computation
There will be an assignment at the end of the program (100% of the final grade). 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.