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所在平台: Coursera |
课程主页: https://www.coursera.org/learn/clinical-trials
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课程名称：临床试验的设计与解读 课程概述： 临床试验是通过实验来评估新干预措施对人类疾病预防或治疗效果的研究。这些干预措施可能包括药物、设备（如助听器）、手术、行为干预（如戒烟计划）、社区健康项目（如癌症筛查项目）或健康服务系统（如住院病人的特护病房）。临床试验被视为实验，因为治疗的选择由研究者决定，而非患者或其医生。随机临床试验的结果通常被认为是评估治疗效果的最高证据水平，因为这些试验具备确保评价治疗的收益与风险时客观和无偏的特征。美国食品药品监督管理局（FDA）要求药物或生物制品（如疫苗）在销售前必须通过临床试验证明其有效性。 课程内容将解释随机临床试验设计的基本原则及其报告方式。在课程的前半部分，学生将学习临床试验中使用的术语以及几种常见的试验设计，如平行设计和互换设计。同时，我们将讲解临床试验的一些基本机制，如随机化和治疗的盲法处理。在课程的后半部分，我们将讨论如何分析和解读临床试验的结果。最后，我们将回顾在进行人体实验时必须考虑的伦理问题。 课程大纲： 1. 试验设计类型：本周探讨不同类型的试验设计，包括平行设计、交叉设计、分组分配、因子设计、大型简单设计、等效设计、非劣设计和适应性设计。 2. 随机化与盲法处理：本周讨论随机临床试验的两个关键设计特征：随机化和盲法处理，以防止偏倚。 3. 结果与分析：本周重点探讨关键设计问题——选择主要结果。同时，我们将讨论临床试验分析的金标准，即将所有参与者纳入分析，不论其实际接受的治疗。 4. 伦理：本周重点讨论临床试验领域的一个关键问题——人与实验的伦理。 5. 报告结果：本周重点聚焦临床试验结果在出版物中的报告。我们将涵盖临床试验报告的标准（CONSORT）指南。 6. 随机临床试验：本周探讨随机对照试验（RCT）是否仍然是评估证据的金标准。 该课程为希望深入了解临床试验设计与实施的学生提供了系统的学习机会。
Name:Types of Trial Designs
Description:This week, we explore different types of trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs.
Name:Randomization and Masking
Description:This week we discuss two key design features of randomized clinical trials used to protect against bias, randomization and masking.
Name:Outcomes and Analysis
Description:This week focuses on a key design issue - selecting the primary outcome. We will also cover the gold standard for analysis of clinical trials, which is including all the participants in the analysis regardless of their actual treatment.
Name:Ethics
Description:This week focuses on a key issue in the field of clinical trials, the ethics of experimentation in humans.
Name:Reporting Results
Description:This week, we focus on reporting results of clinical trials in publications. We cover the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Name:Randomized Clinical Trials
Description:This week, we focus on whether RCTs are still the gold standard for evaluating evidence.
Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). We consider clinical trials experiments because the investigators rather than the patients or their doctors select the treatment the patients receive. Results from randomized clinical trials are usually considered the highest level of evidence for determining whether a treatment is effective because trials incorporates features to ensure that evaluation of the benefits and risks of treatments are objective and unbiased. The FDA requires that drugs or biologics (e.g., vaccines) are shown to be effective in clinical trials before they can be sold in the US. The course will explain the basic principles for design of randomized clinical trials and how they should be reported. In the first part of the course, students will be introduced to terminology used in clinical trials and the several common designs used for clinical trials, such as parallel and cross-over designs. We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment. In the second half of the course, we will explain how clinical trials are analyzed and interpreted. Finally, we will review the essential ethical consideration involved in conducting experiments on people.
