Design and Interpretation of Clinical Trials

开始时间: 03/09/2015 持续时间: 6 weeks

所在平台: Coursera

课程类别: 医学

大学或机构: Johns Hopkins University(约翰•霍普金斯大学)

授课老师: Lea T. Drye Janet Holbrook



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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 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.


The course will mainly focus on the nuts and bolt of clinical trials design.  Lecture topics are:
  • Terminology and Common Trial Designs
  • Randomization – what is it and how do we do it
  • Blinding treatment – why and how we keep everyone in the dark about the treatment
  • Selecting outcome – good and bad ones
  • Analyzing the data – principle of intention-to-treat, why it’s not crazy
  • Reporting the results – CONSORT guidelines, a good road map for readers and writers
  • Ethical issues – why they are important and what they are





Learn the basic principles for design of randomized clinical trials and how they should be reported.