Vaccine Trials: Methods and Best Practices

开始时间: 待定 持续时间: Unknown

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: Karen R. Charron Amber Bickford Cox

   

课程主页: https://www.coursera.org/course/vacctrials

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课程评论: 1 个评论

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课程详情

Vaccines are evaluated through a series of clearly defined controlled studies to assess these investigational products for safety, immunogenicity and efficacy before they are approved for licensure.  All clinical vaccine trials are bound by international ethical guidelines and, in the case of US trials, Food and Drug Administration (FDA) regulations.
 
Good Clinical Practice is defined by the International Conferences on Harmonization (ICH) as: “A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.”
 
That’s a tall order, so how is it done?  Individuals who enroll as subjects in these trials play an essential role in the development and evaluation of new and improved candidate vaccines.  They are average citizens who volunteer to roll up their sleeves and, in the process, make a tremendous difference in society.  So why do they volunteer and what safeguards do we put in place to protect their rights, safety and well-being while in the trial?  What are the responsibilities of the investigators, sponsors and ethics committees who conduct and oversee these trials? 
 
Along with our colleagues, we will introduce you to how GCP is applied in clinical vaccine trials to ensure proper and ethical scientific conduct. The course will use examples from real vaccine trials to demonstrate the application of the FDA Code of Federal Regulations and ICH GCP Guidelines to explore methods and best practices involved in implementing phase I and II vaccine clinical trials.  This short course offering through Coursera is based on our work at the Center for Immunization Research and an in-depth graduate course taught at the Johns Hopkins Bloomberg School of Public Health.
 
We hope it inspires you to work in this exciting field.

课程大纲

This course will cover the following topics: A brief review of vaccine history and types; how vaccine trials are conducted, including which data are collected and how those data are managed and evaluated; appropriate processes to ensure human subjects protection and informed consent; methods for recruitment and enrollment of participants; and vaccine safety assessment. Upon successfully completing this course, students will be able to:

  • Describe the types of vaccines in use today
  • Describe how vaccines are evaluated in phase I and II clinical trials
  • Identify key regulatory requirements, considerations and ethical standards for human subjects protection and informed consent. 
  • Discuss how clinical trials are conducted with an emphasis on quality data and protection of the rights, safety and well-being of volunteers.

课程评论(1条)

0

MarTierra 2013-08-13 03:31 0 票支持; 0 票反对

If you haven't had experience in working in a clinical trial environment, this course wud be EXTREEEEMELY boring... it's all about operation, not theory, nor methods. 就因为太boring了我从lecture 3之后全都拖着拖着到课程截止日期前一天才开工,lecture也听不下去就把quiz全都对着讲义给做了。Just for the purpose of exposure... know what the fuss vaccine trials are about and how they're operated.

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课程简介

This course will explore the process of evaluating investigational vaccines in clinical trials including informed consent, recruitment, enrollment, safety evaluation, and quality data collection.

课程标签

医学 疫苗 实验 疫苗实验 疫苗方法 疫苗实践 疫苗试验 约翰霍普金斯 约翰霍普金斯大学

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