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所在平台: Coursera |
课程主页: https://www.coursera.org/learn/design-and-conduct-clinical-trials
课程评论：没有评论
课程名称：临床试验的设计与实施 课程概述：本课程将教您如何设计和实施临床试验。每个设计选择都将影响结果的质量和有效性。本课程为您和您的团队提供了评估选项、做出良好设计选择和在试验中实施这些选择的基本技能。您将学习如何控制偏倚、随机化参与者、遮蔽治疗和结果、识别错误、发展和测试假设以及定义适当的结果。最后，试验没有参与者就无法完成。 课程大纲： 1. **偏倚控制：随机化与遮蔽** - 描述：每个试验设计都依赖于核心设计元素的熟练应用。本模块将介绍各种偏倚控制方法以及对试验参与者进行简单、限制性和自适应随机化的方法。最后，您将学习如何通过遮蔽程序保护结果的有效性，在必要时向研究团队、参与者和结果评估者隐瞒治疗和结果。 2. **试验阶段和设计** - 描述：每个试验分阶段进行，因此您和您的团队需要对每个阶段做出合理的设计选择。这包括制定和评估研究问题和假设、选择不同的设计类型以及识别错误。 3. **临床试验中的结果** - 描述：良好定义的结果是任何良好试验设计的基础。您和您的团队在设计过程开始时设定的结果将影响其他设计决策，如试验类型、随机化、遮蔽、样本大小等。 4. **临床试验中的伦理问题：知情同意** - 描述：试验参与者必须受到极大的尊重，从仔细关注知情同意开始。本模块将介绍在您的试验中规划和实施伦理有效的知情同意程序所需的人员、文件、术语和实践。 5. **招募与留存** - 描述：没有参与者的试验根本算不上试验。在本模块中，您将学习如何伦理且有效地招募和留存试验所需的参与者，并战略性地选择进行研究的临床地点。
Name:Bias Control: Randomization and Masking
Description:Every trial design depends on the skilled application of core design elements. In this module, you’ll learn about various approaches to bias control as well as simple, restricted, and adaptive approaches to trial participant randomization. Finally, you’ll learn to protect the validity of your results with masking procedures that conceal treatments and outcomes as necessary from the study team, participants, and outcomes assessors.
Name:Trial Stages and Designs
Description:Each trial is conducted in stages, so it’s critical that you and your team are prepared to make sound design choices for each stage. That includes developing and evaluating research questions and hypotheses, selecting among various design types, and identifying errors.
Name:Outcomes in Clinical Trials
Description:Well-defined outcomes are the foundation of any good trial design. The outcomes that you and your team establish at the beginning of the design process will influence other design decisions such as trial type, randomization, masking, sample size, and more.
Name:Ethical Issues in Clinical Trials: Informed Consent
Description:Trials participants must be treated with the utmost respect, and that begins with careful attention to informed consent. In this module, you’ll learn about the personnel, documents, terminology, and practices that go into planning and implementing ethically sound informed consent procedures within your trial.
Name:Recruitment and Retention
Description:A trial without participants is no trial at all. In this module, you’ll learn how to ethically and effectively recruit and retain the participants you need for your trial and strategically select the clinical sites where you’ll conduct your research.
In this course, you’ll learn how to design and carry out clinical trials. Each design choice has implications for the quality and validity of your results. This course provides you and your team with essential skills to evaluate options, make good design choices, and implement them within your trial. You’ll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. Finally, a trial without partic
