StudyDesign

Project PI20/00377 ISCII

Development of a simulation environment as a tool to support the design of studies and clinical trials

The design of a study is a critical phase that fixes the range of possible analyses that can be done and limits possible conclusions that come from the results. As such, the evaluating committees of projects, clinical trials, and publications pay special attention to the study design and often dismiss proposals that are not sufficiently reasoned and justified. This project will develop study simulation tools that allow an adequate discussion of the implications of a design facilitating interaction between clinical and statistical researchers.

  Catalog of statistical concepts and common designs in biomedical research

Here we offer an overview of trial design, delving into fundamental statistical concepts and exploring common clinical trial methodologies. It clarifies key principles such as randomization, blinding, and sample size determination, while discussing various approaches to structuring and executing clinical studies. By examining the strengths and limitations of different trial designs, this option provides valuable insights for both novice researchers and experienced clinicians, ensuring a well-rounded understanding of the complexities involved in planning robust and effective clinical trials.

 

  Tools for exploring trial design

There are many useful tools available for calculating sample size in clinical trials, which can help you plan your trial effectively. Our tools offer added value by using simulations to explore the expected results of specific design choices. We encourage you to experiment with these tools to build confidence in both the underlying concepts and the practical decisions involved.

  Research Team

Albert Sorribas (IP)    Ester Vilaprinyo (IP)  Rui Alves  Miguel Ángel Escobar   Xavier Gómez  Pedro Sandoval  Jose Serrano

Collaborators

Laboratory Clínic Hospital Universitary Arnau de Vilanova

Unitat de Cures Intensives Hospital Universitary Arnau de Vilanova

Institutions