|
所在平台: Coursera |
课程主页: https://www.coursera.org/learn/clinical-trials-analysis-presentation-statistical-monitoring
课程评论：没有评论
课程名称：临床试验分析、监测与报告 课程概述：在本课程中，您将学习进行成功临床试验所需的更高级操作技能。您将了解到样本量的计算方法，并学习如何开发适合您的试验设计和结果指标的样本量计算。您还将学习使用统计方法来监测试验的安全性、完整性和有效性。接下来，您将了解如何通过期刊文章和数据监测报告来呈现临床试验的结果。 课程大纲： 1. **临床试验样本量计算**：本模块将介绍如何确定试验所需的样本量，以合理预期检测组间差异。最终结果是样本量的估算。 2. **试验监测**：您将学习试验监测的统计方法，用于评估试验在进行中的安全性、完整性、有效性、招募、数据收集及数据质量。 3. **随机临床试验结果报告**：有效沟通临床试验结果对于确保您的努力产生预期影响至关重要。本模块将教授在期刊发表和数据监测报告中报告结果的最佳实践。 4. **试验分析**：分析师在试验过程中发挥着重要作用，您将学习分析师在每个阶段如何为试验做出贡献。 5. **高级主题**：本模块将介绍一些高级操作功能，如仿真、适应性设计和贝叶斯统计，这些均应成为您试验团队的工具箱的一部分。 通过本课程的学习，您将能够掌握临床试验的核心技能，从而为成功的临床试验奠定坚实的基础。
Name:Clinical Trial Sample Size
Description:Sample size calculation in clinical trials refers to the process for determining how large a trial needs to be in order to have a reasonable expectation of detecting a difference between groups. The end result of the sample size calculation should be an estimate of the number of observations.
Name:Trial Monitoring
Description:In this module, you’ll learn about trial monitoring, which involves statistical methods to assess a trial while it is underway. These methods are used to assess safety, integrity, efficacy, recruitment, data collection, and data quality.
Name:Reporting Results From Randomized Clinical Trials (RCTs)
Description:Skilled communication of your clinical trial results is critical to ensuring that your efforts have the intended impact. In this module, you’ll learn the best practices for reporting results in both journal publications and in data monitoring reports.
Name:Analyzing Trials
Description:Analysts play an important role throughout the trial, not just at the end. In this module, you’ll learn about the analyst’s role, including how the analyst contributes to the trial at every stage of the process.
Name:Advanced Topics
Description:In this module, you’ll learn about some advanced operational functions that should be in your trial team’s toolkit, including simulations, adaptive designs, and Bayesian statistics.
In this course, you’ll learn more advanced operational skills that you and your team need to run a successful clinical trial. You’ll learn about the computation of sample size and how to develop a sample size calculation that’s suitable for your trial design and outcome measures. You’ll also learn to use statistical methods to monitor your trial for safety, integrity, and efficacy. Next, you’ll learn how to report the results from your clinical trials through both journal articles and data monit
