Design and Interpretation of Clinical Trials from Coursera

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.

What's inside

Syllabus

Types of Trial Designs

This week, we explore different types of trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs.

Traffic lights

Read about what's good

what should give you pause

and possible dealbreakers

Explores randomized clinical trials, which is a methodology foundational to healthcare research

Taught by Janet Holbrook, who is a recognized epidemiologist and Lea Drye, who is a registered dietitian

Includes information about reporting results of clinical trials in publications

Provides an overview of the ethical considerations that apply to conducting randomized controlled trials

Grounds this course with case studies in the healthcare patient domain

Teaches a wide variety of clinical trial designs, including parallel, crossover, group allocation, factorial, large simple, equivalency, non-inferiority, and adaptive designs

Reviews summary

Foundational guide to clinical trials

According to learners, this Johns Hopkins course provides a strong foundational understanding of the design and interpretation of clinical trials. Many reviewers highlight the clarity of the lectures and the expertise of the instructors, finding the content well-structured and the pace appropriate for beginners. While the course covers essential concepts like randomization, blinding, outcomes, and ethics thoroughly, some students noted that the statistical analysis sections can be challenging, particularly for those without a prior quantitative background. Overall, it is seen as an excellent introduction for anyone entering or working in the field, though some feel it serves more as a solid base than a deep dive into complex practical applications.

More theoretical base than hands-on application.

"It's a great theoretical foundation, but I was hoping for more practical application examples."

"Provides the 'why' and 'how' but less on the 'do' in a real-world setting."

"Good starting point, but you'll likely need more specialized training for practical trial management or analysis."

In-depth and important coverage of ethics.

"The section on ethics was particularly valuable and well-explained."

"Appreciated the focus on ethical considerations in human experimentation."

"The ethics module was very thorough and highlighted crucial aspects of clinical trials."

"Found the ethics discussion thought-provoking and highly relevant to the field."

Provides a solid basis for clinical trials.

"This course gives an excellent overview and foundational understanding of clinical trials."

"I learned so much about the fundamental principles, like randomization and blinding."

"Great course for anyone looking to get a solid introduction to the subject."

"It covers all the essential aspects needed to understand trial design and interpretation."

Expert instructors explain complex ideas clearly.

"The instructor is very clear and breaks down complex concepts into understandable parts."

"Professor takes time to explain each topic deeply, making the material easy to grasp."

"I really enjoyed the teaching style, the explanations were always spot on and easy to follow."

"The instructors were very knowledgeable and excellent at explaining the material."

Analysis sections can be challenging without stats background.

"The statistical parts were a bit difficult for me as I don't have a strong stats background."

"Needed to supplementary resources for some of the data analysis concepts discussed."

"Understanding the analysis requires some prior quantitative knowledge; it's not always easy for newcomers."

"While the course is great, the analytical modules were the steepest part of the learning curve."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Design and Interpretation of Clinical Trials with these activities:

Review Biostatistics

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Strengthen foundational knowledge of biostatistics to better understand and interpret results from clinical trials.

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Review fundamental concepts of probability and distributions
Refresh knowledge of hypothesis testing and statistical significance
Cover advanced topics such as regression and ANOVA

Solve Clinical Trial Design Problems

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Develop problem-solving skills by applying design principles to real-world scenarios in clinical trials.

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Work through structured exercises and case studies
Apply randomization and blinding principles to design simulation studies

Navigate CONSORT Guidelines

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Enhance understanding of ethical considerations and reporting standards in clinical trials.

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Follow online tutorials or webinars
Review examples and case studies of published trials

One other activity

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Develop a Clinical Trial Protocol

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Apply knowledge gained to design and write a comprehensive clinical trial protocol.

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Identify a research question and define objectives
Design a study plan and select appropriate participants
Develop outcome measures and analysis plan

Career center

Learners who complete Design and Interpretation of Clinical Trials will develop knowledge and skills that may be useful to these careers:

Clinical Research Coordinator

A Clinical Research Coordinator plays a vital role in the design and implementation of clinical trials. This course would be extremely useful to someone in this role because it provides a comprehensive overview of the principles of clinical trial design, including randomization, blinding, and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Clinical Data Manager

A Clinical Data Manager is responsible for managing the data collected in clinical trials. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the regulatory requirements for clinical trials, which is essential knowledge for anyone working in this field.

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Biostatistician

A Biostatistician designs and analyzes statistical methods for clinical trials. This course would be very useful to someone in this role because it provides a comprehensive overview of the principles of clinical trial design and data analysis, including randomization, blinding, and power calculations. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Epidemiologist

An Epidemiologist investigates the causes of disease and other health problems in populations. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Medical Writer

A Medical Writer creates documents that communicate medical information to a variety of audiences. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Pharmacist

A Pharmacist dispenses medications and provides advice on their use. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Physician

A Physician diagnoses and treats diseases and injuries. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Regulatory Affairs Specialist

A Regulatory Affairs Specialist ensures that clinical trials are conducted in compliance with all applicable regulations. This course would be very useful to someone in this role because it provides a comprehensive overview of the principles of clinical trial design and data analysis, including randomization, blinding, and power calculations. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Research Scientist

A Research Scientist conducts research to develop new treatments and cures for diseases. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Science Writer

A Science Writer communicates complex scientific information to a variety of audiences. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Statistician

A Statistician collects, analyzes, interprets, and presents data. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis, including randomization, blinding, and power calculations. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Toxicologist

A Toxicologist studies the effects of chemicals on living organisms. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Health Policy Analyst

A Health Policy Analyst analyzes and evaluates health policies and programs. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Project Manager

A Project Manager plans, executes, and closes projects. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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Quality Assurance Specialist

A Quality Assurance Specialist ensures that products and services meet quality standards. This course would be very useful to someone in this role because it provides a strong foundation in the principles of clinical trial design and data analysis. The course also covers the ethical considerations involved in conducting clinical trials, which is essential knowledge for anyone working in this field.

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