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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
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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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