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This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical trials research. Topics include the design, implementation, and analysis of trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II-III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, treatments, and endpoints.  

Assessment

This course does not involve any written exams. Students need to answer 5 assignment questions to complete the course, the answers will be in the form of written work in pdf or word. Students can write the answers in their own time. Each answer needs to be 200 words (1 Page). Once the answers are submitted, the tutor will check and assess the work.

Certification

Edukite courses are free to study. To successfully complete a course you must submit all the assignment of the course as part of the assessment. Upon successful completion of a course, you can choose to make your achievement formal by obtaining your Certificate at a cost of £49.

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Course Credit: Harvard University

Course Curriculum

Module: 01
Introduction to Fundamentals of Clinical Trials 00:05:00
Week 1 Introduction Video 00:02:00
Why are clinical trials important? Lecture 00:22:00
Clinical Trials to Improve Human Health Lecture 00:20:00
What Makes Clinical Research Ethical? Lecture 00:18:00
Week 2 Introduction Video 00:03:00
Early Clinical Trials Lecture 00:19:00
Designing First in Human Studies Lecture 00:21:00
Ethical Issues in Early Stage Research Lecture 00:18:00
Week 3 Introduction Video 00:03:00
Phase 2 and Phase 3 Clinical Trials Lecture 00:17:00
Module: 02
Choosing the Question Lecture 00:39:00
The Fundamental Ethical Dilemma Lecture 00:12:00
Week 4 Introduction Video 00:01:00
Defining the Study Population Lecture 00:34:00
Defining the Treatment Groups Lecture 00:35:00
Ethical Issues in Selection of Control Groups Lecture 00:14:00
Week 5 Introduction Video 00:02:00
Defining the Outcomes Lecture 00:22:00
The Statistical Analysis Plan Lecture 00:23:00
Week 6 Introduction Video 00:03:00
Module: 03
Sample Size and Power I: Binary Outcomes Lecture 00:23:00
Sample Size and Power II: Measured Outcomes Lecture 00:16:00
Sample Size and Power: Time to Event Outcomes Lecture 00:19:00
Week 7 Introduction Video 00:01:00
Baseline Assessment Lecture 00:19:00
Randomization Lecture 00:22:00
Data Monitoring Lecture 00:22:00
Introduction to week 8 video 00:03:00
Data Analysis I: Continuous Variables Lecture 00:21:00
Module: 04
Data Analysis II: Binary Outcomes Lecture 00:17:00
Data Analysis III: Time to Event Endpoints Lecture 00:27:00
Week 9 Introduction Video 00:01:00
Interpretation of Study Findings Part I Lecture 00:23:00
Interpretation of Study Findings Part II Lecture 00:16:00
Week 10 Introduction Video 00:02:00
Surveillance Part I Lecture 00:18:00
Surveillance Part II Lecture 00:17:00
Week 11 Introduction Video 00:02:00
Non-inferiority Trials Part I Lecture 00:21:00
Non-inferiority Trials Part II Lecture 00:20:00
Pragmatic Trials Lecture 00:17:00
Course Summary 00:15:00
Assessment
Submit Your Assignment 00:00:00
Certification 00:00:00

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