Clinical Trials Analysis, Monitoring, and Presentation

Johns Hopkins University

In this course, offered by Johns Hopkins University, you will gain advanced operational skills essential for conducting successful clinical trials. Throughout the comprehensive curriculum, you will delve into diverse topics such as sample size computation, trial monitoring, result analysis, and effective communication of trial outcomes.

  • Learn to calculate the sample size required for your trial design and outcome measures.
  • Understand the statistical methods used to monitor trial safety, integrity, and efficacy.
  • Discover how to effectively report clinical trial results through journal articles and data monitoring reports.
  • Explore the role of the analyst throughout the trial process and delve into advanced topics such as simulations and adaptive designs.

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Clinical Trials Analysis, Monitoring, and Presentation
Course Modules

The course includes detailed modules covering sample size calculation, trial monitoring, reporting results, trial analysis, and advanced topics such as simulations and adaptive designs.

Clinical Trial Sample Size

This module covers essential aspects of clinical trial sample size calculation, including definitions, assumptions, practical considerations, bias control, randomization, and masking. By mastering these concepts, you will be equipped to accurately determine the required sample size for your clinical trial design and outcome measures.

Trial Monitoring

Delve into the goals and responsibilities of trial monitoring, interim analyses, statistical monitoring, and safety versus efficacy data. Gain insights into effective trial monitoring practices to ensure the safety, integrity, and efficacy of your clinical trial throughout its duration.

Reporting Results From Randomized Clinical Trials (RCTs)

Learn the intricacies of reporting results from randomized clinical trials, covering journal articles, data monitoring reports, and the essential elements of presenting results effectively. This module provides comprehensive guidance on communicating the outcomes of clinical trials through various reporting channels.

Analyzing Trials

This module delves into the role of the analyst throughout the trial process, the development of a statistical analysis plan, considerations for the analysis population, and different types of analyses. Gain a deeper understanding of the analytical aspects essential for deriving meaningful insights from clinical trial data.

Advanced Topics

Explore advanced topics in clinical trials, including simulations, adaptive designs, Bayesian approaches, and their applications in optimizing trial processes. This module provides valuable insights into innovative methodologies that can enhance the efficiency and effectiveness of clinical trials.

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