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Janet Holbrook, PhD, MPH,
Ann-Margret Ervin, PhD, MPH,
Stephan Ehrhardt, MD, MPH,
and
Elizabeth A. Sugar, PhD
In this course, you’ll learn how to design and carry out clinical trials. Each design choice has implications for the quality and validity of your results. This course provides you and your team with essential skills to evaluate options, make good design choices, and implement them within your trial. You’ll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. Finally, a trial without participants is no trial at all, so you’ll learn the guiding principles and develop the essential skills to ethically and conscientiously recruit, obtain consent from, and retain trial participants.
Register for this course and see more details by visiting:
OpenCourser.com/course/3itaby/design
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What's inside
Syllabus
Bias Control: Randomization and Masking
Every trial design depends on the skilled application of core design elements. In this module, you’ll learn about various approaches to bias control as well as simple, restricted, and adaptive approaches to trial participant randomization. Finally, you’ll learn to protect the validity of your results with masking procedures that conceal treatments and outcomes as necessary from the study team, participants, and outcomes assessors.
Read more
Syllabus
Bias Control: Randomization and Masking
Every trial design depends on the skilled application of core design elements. In this module, you’ll learn about various approaches to bias control as well as simple, restricted, and adaptive approaches to trial participant randomization. Finally, you’ll learn to protect the validity of your results with masking procedures that conceal treatments and outcomes as necessary from the study team, participants, and outcomes assessors.
Read more
Traffic lights
Traffic lights
Read about what's good
what should give you pause and
possible dealbreakers
Guides learners through the design and administration of clinical trials
Covers core design elements like bias control, randomization, and masking
Emphasizes ethical considerations, particularly in obtaining informed consent
Provides guidance on recruiting and retaining participants effectively
Designed for individuals involved in clinical trial research, including researchers and healthcare professionals
Taught by experienced instructors with expertise in clinical trial design and execution
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Reviews summary
Rigorous training in clinical trial design
According to students, this course offers a comprehensive and rigorous foundation for designing and conducting clinical trials. Many found the lectures clear and well-structured, appreciating the in-depth coverage of topics like bias control, randomization, masking, and especially the thorough module on ethical considerations and informed consent. It is seen as highly valuable for career progression and enhancing confidence in trial design. However, some learners noted the course is quite theoretical, expressing a desire for more practical exercises or real-world case studies. A few reviews indicated the pace can be challenging and may assume prior statistical knowledge, making it potentially less ideal for complete beginners.
Provides a thorough and practical focus on ethical issues.
"I particularly appreciated the module on ethical considerations and informed consent; it was very thorough and practical."
"Incredible depth and clarity. The ethical considerations module was a highlight, emphasizing the human aspect of trials."
"The course truly empowers me to make informed design choices, especially regarding participant treatment and consent."
Offers an excellent and comprehensive foundation.
"This course provided an excellent foundation for understanding clinical trials. The lectures were clear and well-structured, making complex topics digestible."
"Outstanding course! The content is comprehensive, covering everything from bias control to participant recruitment."
"I feel much more confident in my ability to design and conduct trials now. It's very valuable for my career progression."
Primarily lecture-based, some desire more interactive elements.
"Good overview, but I wish there were more interactive elements or practical assignments."
"It's largely lecture-based, which can be dry at times. The information is top-notch, but the delivery could be more engaging."
"The course structure felt a bit disjointed at times. Some lectures were very detailed, others rushed."
Primarily focuses on theoretical principles, less practical.
"Some parts felt a bit theoretical, and I would have loved more real-world case studies or practical exercises to solidify the concepts."
"Content is excellent... The course is very theoretical, which is good for understanding principles, but less so for hands-on application."
"I was looking for more how-to guides and real-world examples. This felt like a university lecture series, not for immediate application."
Challenging pace and assumes some prior statistical background.
"The course has good information, but I found the pace quite challenging. It assumes a certain level of prior knowledge..."
"I found this course somewhat difficult to follow, especially without a strong background in statistics."
"It felt more like an advanced course than an introductory one. Maybe it needs clearer prerequisites."
"It's good for a refresher, but maybe overwhelming for a complete beginner."
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 Conduct of Clinical Trials with these
activities:
Read Clinical Trials: A Methodological Perspective
Show steps
This comprehensive book provides an in-depth exploration of the methodological aspects of clinical trials, complementing the foundational knowledge gained in this course.
View
Clinical Trials
on Amazon
Show steps
-
Read Chapters 1-3 to gain an overview of clinical trial design.
-
Complete the end-of-chapter exercises in Chapters 1-3 to test your understanding.
-
Review the solved examples throughout the book to see how methodological concepts are applied in practice.
Review Medical Biostatistics
Show steps
This book's comprehensive coverage of medical biostatistics can provide the foundational knowledge needed to perform and interpret clinical research in this course.
View
Statistical Methods in Medical Research
on Amazon
Show steps
-
Read Chapters 1-5 to gain an understanding of basic biostatistical concepts.
-
Complete the end-of-chapter exercises in Chapters 1-5 to test your understanding.
-
Review the solved examples throughout the book to see how biostatistical concepts are applied in practice.
Join a Study Group for Clinical Trial Design
Show steps
Join a study group to discuss and collaborate on clinical trial design concepts, fostering a deeper understanding of the material covered in this course.
Browse courses on
Clinical Trial Design
Show steps
-
Find a study group or create your own.
-
Meet regularly to discuss course material.
-
Work together on practice problems and assignments.
Five other activities
Expand to see all activities and additional details
Show all eight activities
Practice Randomization Techniques
Show steps
Practice randomization techniques to solidify your understanding of how to minimize bias in clinical trials, which is a core concept in this course.
Browse courses on
Randomization
Show steps
-
Generate a list of 100 participants and assign them to treatment groups using simple randomization.
-
Use a random number generator to assign participants to treatment groups in a block randomization design.
-
Compare the results of simple and block randomization to see how they affect the distribution of participants across treatment groups.
Follow Tutorials on Masking Techniques
Show steps
Follow tutorials to learn different masking techniques and their role in reducing bias in clinical trials, a key topic covered in this course.
Browse courses on
Masking
Show steps
-
Watch a video tutorial on single-blinding.
-
Read an article on double-blinding.
-
Complete an interactive tutorial on triple-blinding.
Attend a Workshop on Patient Recruitment and Retention
Show steps
Attend a workshop to learn strategies for recruiting and retaining participants in clinical trials, a crucial aspect covered in this course.
Show steps
-
Find a workshop on patient recruitment and retention.
-
Attend the workshop.
-
Apply what you learned to your own research or practice.
Design a Randomized Controlled Trial
Show steps
Design a randomized controlled trial to apply the principles of bias control and randomization learned in this course.
Browse courses on
Randomized Controlled Trials
Show steps
-
Define the research question and hypothesis.
-
Select a study population and sample size.
-
Choose a randomization method.
-
Develop a data collection plan.
-
Write a protocol for the trial.
Contribute to an Open-Source Clinical Trial Management System
Show steps
Contribute to an open-source clinical trial management system to gain practical experience in the field and solidify your understanding of the principles taught in this course.
Show steps
-
Find an open-source clinical trial management system.
-
Identify an area where you can contribute.
-
Submit a pull request with your contribution.
Read Clinical Trials: A Methodological Perspective
Show steps
This comprehensive book provides an in-depth exploration of the methodological aspects of clinical trials, complementing the foundational knowledge gained in this course.
View
Clinical Trials
on Amazon
Show steps
Show steps
Show steps
- Read Chapters 1-3 to gain an overview of clinical trial design.
- Complete the end-of-chapter exercises in Chapters 1-3 to test your understanding.
- Review the solved examples throughout the book to see how methodological concepts are applied in practice.
Review Medical Biostatistics
Show steps
This book's comprehensive coverage of medical biostatistics can provide the foundational knowledge needed to perform and interpret clinical research in this course.
View
Statistical Methods in Medical Research
on Amazon
Show steps
Show steps
Show steps
- Read Chapters 1-5 to gain an understanding of basic biostatistical concepts.
- Complete the end-of-chapter exercises in Chapters 1-5 to test your understanding.
- Review the solved examples throughout the book to see how biostatistical concepts are applied in practice.
Join a Study Group for Clinical Trial Design
Show steps
Join a study group to discuss and collaborate on clinical trial design concepts, fostering a deeper understanding of the material covered in this course.
Browse courses on
Clinical Trial Design
Show steps
Show steps
Show steps
- Find a study group or create your own.
- Meet regularly to discuss course material.
- Work together on practice problems and assignments.
Five other activities
Expand to see all activities and additional details
Show all eight activities
Practice Randomization Techniques
Show steps
Practice randomization techniques to solidify your understanding of how to minimize bias in clinical trials, which is a core concept in this course.
Browse courses on
Randomization
Show steps
Show steps
Show steps
- Generate a list of 100 participants and assign them to treatment groups using simple randomization.
- Use a random number generator to assign participants to treatment groups in a block randomization design.
- Compare the results of simple and block randomization to see how they affect the distribution of participants across treatment groups.
Follow Tutorials on Masking Techniques
Show steps
Follow tutorials to learn different masking techniques and their role in reducing bias in clinical trials, a key topic covered in this course.
Browse courses on
Masking
Show steps
Show steps
Show steps
- Watch a video tutorial on single-blinding.
- Read an article on double-blinding.
- Complete an interactive tutorial on triple-blinding.
Attend a Workshop on Patient Recruitment and Retention
Show steps
Attend a workshop to learn strategies for recruiting and retaining participants in clinical trials, a crucial aspect covered in this course.
Show steps
Show steps
Show steps
- Find a workshop on patient recruitment and retention.
- Attend the workshop.
- Apply what you learned to your own research or practice.
Design a Randomized Controlled Trial
Show steps
Design a randomized controlled trial to apply the principles of bias control and randomization learned in this course.
Browse courses on
Randomized Controlled Trials
Show steps
Show steps
Show steps
- Define the research question and hypothesis.
- Select a study population and sample size.
- Choose a randomization method.
- Develop a data collection plan.
- Write a protocol for the trial.
Contribute to an Open-Source Clinical Trial Management System
Show steps
Contribute to an open-source clinical trial management system to gain practical experience in the field and solidify your understanding of the principles taught in this course.
Show steps
Show steps
Show steps
- Find an open-source clinical trial management system.
- Identify an area where you can contribute.
- Submit a pull request with your contribution.
Career center
Learners who complete Design and Conduct of Clinical Trials will develop knowledge and skills
that may be useful to these careers:
Clinical Research Associate
Clinical Research Associate
Clinical Research Associates (CRAs) manage clinical trials by overseeing the day-to-day operations of the study and ensuring that the study is conducted in accordance with Good Clinical Practice (GCP) guidelines. The Design and Conduct of Clinical Trials would be useful for those in this role as it will teach them the essential skills needed to design and conduct clinical trials, including how to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes.
Clinical Trial Manager
Clinical Trial Manager
Clinical Trial Managers oversee the day-to-day operations of clinical trials. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge is essential for managing clinical trials and ensuring that they are conducted in accordance with Good Clinical Practice (GCP) guidelines.
Biostatistician
Biostatistician
Biostatisticians apply statistical methods to solve problems in biology, medicine, and public health. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which are a type of study that is used to test the effectiveness of new treatments. This knowledge is essential for designing and conducting valid and reliable clinical trials.
Statistician
Statistician
Statisticians analyze data, test hypotheses, and develop models to help answer questions and solve problems. They use a variety of statistical techniques, including design of experiments, data collection, and data analysis. The Design and Conduct of Clinical Trials course can be beneficial to someone in this role because it will teach them how to design and conduct clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. The course will also teach them how to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. This knowledge and these skills are essential for designing and conducting valid and reliable clinical trials.
Research Scientist
Research Scientist
Research Scientists conduct research to develop new knowledge. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge is essential for designing and conducting valid and reliable clinical trials.
Quality Assurance Auditor
Quality Assurance Auditor
Quality Assurance Auditors evaluate the quality of products and services to ensure that they meet regulatory requirements. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge is essential for understanding the regulatory requirements for clinical trials and for ensuring that clinical trials are conducted in accordance with these requirements.
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Regulatory Affairs Specialists ensure that products meet regulatory requirements before they are marketed. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge is essential for understanding the regulatory requirements for clinical trials and for ensuring that products meet these requirements.
Physician
Physician
Physicians diagnose and treat diseases and injuries. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge can be helpful for understanding how new treatments are developed and for making informed decisions about the care of patients.
Health Policy Analyst
Health Policy Analyst
Health Policy Analysts analyze health policy issues and develop recommendations for policy changes. The Design and Conduct of Clinical Trials course would be beneficial for someone in this role because it will help them understand how clinical trials are designed and conducted and how the results of these trials are used to inform health policy decisions.
Epidemiologist
Epidemiologist
Epidemiologists investigate the causes of disease and other health problems in populations. The knowledge gained from this research is used to develop public health programs and policies to prevent and control diseases. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides the opportunity to learn how to design and conduct clinical trials, which may be a part of their research. Additionally, the course teaches how to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. This knowledge and these skills are essential for designing and conducting valid and reliable clinical trials.
Medical Writer
Medical Writer
Medical Writers create written materials about medical and health-related topics for a variety of audiences. These materials can include clinical trial protocols, patient education materials, and marketing materials. The Design and Conduct of Clinical Trials course may be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge can be helpful for writing clinical trial protocols and other materials related to clinical trials.
Pharmacist
Pharmacist
Pharmacists dispense medications and provide information about their use. The Design and Conduct of Clinical Trials course would be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge can be helpful for understanding how new medications are developed and for providing information to patients about these medications.
Nurse
Nurse
Nurses provide care to patients in a variety of settings. The Design and Conduct of Clinical Trials course may be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which can help nurses better understand how new treatments are developed and how to provide care to patients who are participating in clinical trials.
Data Analyst
Data Analyst
Data Analysts collect, clean, and analyze data to identify patterns and trends. They use this information to help businesses make better decisions. The Design and Conduct of Clinical Trials course may be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which is a specialized type of study that is used to test the effectiveness of new treatments. This knowledge can be helpful for understanding how clinical trials are conducted and how the data from these trials can be used to make informed decisions.
Project Manager
Project Manager
Project Managers plan, execute, and close projects. They work with stakeholders to define project goals, develop project plans, and track project progress. The Design and Conduct of Clinical Trials course may be useful for those in this role as it provides an opportunity to learn about the design and conduct of clinical trials, which can help project managers better understand how to plan and execute clinical trials.
For more career information including salaries, visit:
OpenCourser.com/course/3itaby/design
Reading list
We've selected eight books
that we think will supplement your
learning. Use these to
develop background knowledge, enrich your coursework, and gain a
deeper understanding of the topics covered in
Design and Conduct of Clinical Trials.
Save
Is an essential read for students and practitioners in clinical research. It provides detailed information regarding the design, conduct, and analysis of clinical studies, with a focus on efficacy trials and hypothesis testing.
This popular textbook provides a comprehensive overview of the principles and methods used in designing clinical research studies. It covers topics such as formulating research questions, selecting study designs, and conducting data analysis.
This textbook is designed as a practical reference for clinical trial scientists and statisticians. It provides guidance on all aspects of clinical trial design, from planning to analysis.
History of informed consent in clinical trials. It valuable resource for understanding the ethical issues involved in the design and conduct of clinical trials.
Provides a comprehensive overview of the principles and practices of clinical data management. It covers topics such as data collection, data entry, data cleaning, and data analysis.
Provides a comprehensive overview of the statistical methods used in cancer research. It covers topics such as descriptive statistics, probability, hypothesis testing, and regression analysis.
Guide for researchers on the design and conduct of clinical trials.
Save
Basic guide to the design and conduct of clinical trials.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/3itaby/design
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Effort
5 weeks, 1-2 hours/week
Level
Introductory
Via
Coursera
Institution
Johns Hopkins University
Instructors
Janet Holbrook, PhD, MPH
Ann-Margret Ervin, PhD, MPH
Stephan Ehrhardt, MD, MPH
Elizabeth A. Sugar, PhD
Language
English
Transcripts
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This course belongs to a
collection
called
Clinical Trials Operations. It's comprised of four courses:
- Clinical Trials Analysis, Monitoring, and Presentation
- Clinical Trials Management and Advanced Operations
- Design and Conduct of Clinical Trials (viewing)
- Clinical Trials Data Management and Quality Assurance
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