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Janet Holbrook, PhD, MPH,
Elizabeth A. Sugar, PhD,
and
David M. Shade, JD
In this course, you’ll learn more advanced operational skills that you and your team need to run a successful clinical trial. You’ll learn about the computation of sample size and how to develop a sample size calculation that’s suitable for your trial design and outcome measures. You’ll also learn to use statistical methods to monitor your trial for safety, integrity, and efficacy. Next, you’ll learn how to report the results from your clinical trials through both journal articles and data monitoring reports. Finally, we’ll discuss the role of the analyst throughout the trial process, plus a few additional topics such as simulations and adaptive designs.
Register for this course and see more details by visiting:
OpenCourser.com/course/pyj02g/clinical
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What's inside
Syllabus
Clinical Trial Sample Size
Sample size calculation in clinical trials refers to the process for determining how large a trial needs to be in order to have a reasonable expectation of detecting a difference between groups. The end result of the sample size calculation should be an estimate of the number of observations.
Read more
Syllabus
Clinical Trial Sample Size
Sample size calculation in clinical trials refers to the process for determining how large a trial needs to be in order to have a reasonable expectation of detecting a difference between groups. The end result of the sample size calculation should be an estimate of the number of observations.
Read more
Trial Monitoring
In this module, you’ll learn about trial monitoring, which involves statistical methods to assess a trial while it is underway. These methods are used to assess safety, integrity, efficacy, recruitment, data collection, and data quality.
Reporting Results From Randomized Clinical Trials (RCTs)
Skilled communication of your clinical trial results is critical to ensuring that your efforts have the intended impact. In this module, you’ll learn the best practices for reporting results in both journal publications and in data monitoring reports.
Analyzing Trials
Analysts play an important role throughout the trial, not just at the end. In this module, you’ll learn about the analyst’s role, including how the analyst contributes to the trial at every stage of the process.
Advanced Topics
In this module, you’ll learn about some advanced operational functions that should be in your trial team’s toolkit, including simulations, adaptive designs, and Bayesian statistics.
Good to know
Good to know
Know what's good ,
what to watch for , and
possible dealbreakers
Teaches applied methods for designing advanced clinical trials, ensuring reliable data and integrity
Covers complex statistical methods for monitoring and evaluating clinical trials, ensuring data accuracy and validity
Developed by esteemed instructors with extensive experience in clinical trial design and analysis
Provides practical guidance on reporting results, ensuring clear and effective communication of findings
Delves into advanced topics like simulations and Bayesian statistics, expanding learners' analytical toolkit
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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 Clinical Trials Analysis, Monitoring, and Presentation with these
activities:
Review statistics concepts
Show steps
Reviewing these foundational concepts will help you better understand the advanced operational skills taught in this course.
Browse courses on
Descriptive Statistics
Show steps
-
Go through your notes from previous statistics courses.
-
Read through a statistics textbook or online resource.
-
Work through some practice problems.
Find a mentor who is an analyst in clinical trials
Show steps
Gain valuable insights and guidance by connecting with a mentor who has experience as an analyst in clinical trials.
Show steps
-
Network with professionals in the field
-
Attend industry events
-
Reach out to potential mentors for informational interviews
Discuss clinical trial design with peers
Show steps
Discussing clinical trial design with peers will help you to better understand the concepts and methods involved.
Browse courses on
Clinical Trial Design
Show steps
-
Find a group of peers to discuss with.
-
Prepare some questions or topics to discuss.
-
Meet with your group and discuss the topics.
Nine other activities
Expand to see all activities and additional details
Show all 12 activities
Practice calculating sample size
Show steps
Reinforce sample size calculations by solving practice problems.
Browse courses on
Sample Size Calculation
Show steps
-
Review sample size calculation methods
-
Solve sample size calculation problems
Complete sample size calculation exercises
Show steps
Solving these problems will give you practice with the concepts and methods for sample size calculation discussed in the course.
Browse courses on
Sample Size
Show steps
-
Find a set of practice problems online or in a textbook.
-
Work through the problems and check your answers.
-
Review your answers with a tutor or instructor.
Join a study group with other learners taking the course
Show steps
Enhance understanding and retention by discussing course concepts and working on assignments with other learners.
Show steps
-
Find or create a study group with other learners
-
Meet regularly to discuss course materials and assignments
Tutorial on statistical methods for trial monitoring
Show steps
Learn about and practice using statistical methods for monitoring trial safety, integrity, and efficacy through tutorials.
Show steps
-
Find tutorials on statistical methods for trial monitoring
-
Follow the tutorials and complete the exercises
Follow a tutorial on statistical monitoring methods
Show steps
This tutorial will provide you with a step-by-step guide on how to use statistical methods to monitor clinical trials.
Browse courses on
Data Monitoring
Show steps
-
Find a tutorial on statistical monitoring methods.
-
Follow the steps in the tutorial.
-
Apply the methods to a practice dataset.
Practice exercises on statistical methods for clinical trials
Show steps
Improve problem-solving skills by completing practice exercises on statistical methods used in clinical trials.
Browse courses on
Statistical Methods
Show steps
-
Find practice exercises on statistical methods for clinical trials
-
Solve the exercises
Write a data monitoring report
Show steps
Writing a data monitoring report will give you experience with the process of communicating clinical trial results.
Browse courses on
Data Monitoring
Show steps
-
Gather the necessary data.
-
Analyze the data.
-
Write the report.
Case study on reporting clinical trial results
Show steps
Apply knowledge of clinical trial reporting by creating a case study that demonstrates best practices in both journal publications and data monitoring reports.
Show steps
-
Select a clinical trial case study
-
Research best practices in clinical trial reporting
-
Write a journal publication and data monitoring report based on the case study
Compilation of resources on simulation and adaptive designs
Show steps
Expand knowledge on advanced operational functions by gathering and organizing resources on simulation and adaptive designs.
Browse courses on
Simulation
Show steps
-
Search for articles, tutorials, and other resources on simulation and adaptive designs
-
Organize and compile the resources into a single document or collection
Review statistics concepts
Show steps
Reviewing these foundational concepts will help you better understand the advanced operational skills taught in this course.
Browse courses on
Descriptive Statistics
Show steps
Show steps
Show steps
- Go through your notes from previous statistics courses.
- Read through a statistics textbook or online resource.
- Work through some practice problems.
Find a mentor who is an analyst in clinical trials
Show steps
Gain valuable insights and guidance by connecting with a mentor who has experience as an analyst in clinical trials.
Show steps
Show steps
Show steps
- Network with professionals in the field
- Attend industry events
- Reach out to potential mentors for informational interviews
Discuss clinical trial design with peers
Show steps
Discussing clinical trial design with peers will help you to better understand the concepts and methods involved.
Browse courses on
Clinical Trial Design
Show steps
Show steps
Show steps
- Find a group of peers to discuss with.
- Prepare some questions or topics to discuss.
- Meet with your group and discuss the topics.
Nine other activities
Expand to see all activities and additional details
Show all 12 activities
Practice calculating sample size
Show steps
Reinforce sample size calculations by solving practice problems.
Browse courses on
Sample Size Calculation
Show steps
Show steps
Show steps
- Review sample size calculation methods
- Solve sample size calculation problems
Complete sample size calculation exercises
Show steps
Solving these problems will give you practice with the concepts and methods for sample size calculation discussed in the course.
Browse courses on
Sample Size
Show steps
Show steps
Show steps
- Find a set of practice problems online or in a textbook.
- Work through the problems and check your answers.
- Review your answers with a tutor or instructor.
Join a study group with other learners taking the course
Show steps
Enhance understanding and retention by discussing course concepts and working on assignments with other learners.
Show steps
Show steps
Show steps
- Find or create a study group with other learners
- Meet regularly to discuss course materials and assignments
Tutorial on statistical methods for trial monitoring
Show steps
Learn about and practice using statistical methods for monitoring trial safety, integrity, and efficacy through tutorials.
Show steps
Show steps
Show steps
- Find tutorials on statistical methods for trial monitoring
- Follow the tutorials and complete the exercises
Follow a tutorial on statistical monitoring methods
Show steps
This tutorial will provide you with a step-by-step guide on how to use statistical methods to monitor clinical trials.
Browse courses on
Data Monitoring
Show steps
Show steps
Show steps
- Find a tutorial on statistical monitoring methods.
- Follow the steps in the tutorial.
- Apply the methods to a practice dataset.
Practice exercises on statistical methods for clinical trials
Show steps
Improve problem-solving skills by completing practice exercises on statistical methods used in clinical trials.
Browse courses on
Statistical Methods
Show steps
Show steps
Show steps
- Find practice exercises on statistical methods for clinical trials
- Solve the exercises
Write a data monitoring report
Show steps
Writing a data monitoring report will give you experience with the process of communicating clinical trial results.
Browse courses on
Data Monitoring
Show steps
Show steps
Show steps
- Gather the necessary data.
- Analyze the data.
- Write the report.
Case study on reporting clinical trial results
Show steps
Apply knowledge of clinical trial reporting by creating a case study that demonstrates best practices in both journal publications and data monitoring reports.
Show steps
Show steps
Show steps
- Select a clinical trial case study
- Research best practices in clinical trial reporting
- Write a journal publication and data monitoring report based on the case study
Compilation of resources on simulation and adaptive designs
Show steps
Expand knowledge on advanced operational functions by gathering and organizing resources on simulation and adaptive designs.
Browse courses on
Simulation
Show steps
Show steps
Show steps
- Search for articles, tutorials, and other resources on simulation and adaptive designs
- Organize and compile the resources into a single document or collection
Career center
Learners who complete Clinical Trials Analysis, Monitoring, and Presentation will develop knowledge and skills
that may be useful to these careers:
Clinical Trial Manager
Clinical Trial Manager
Clinical Trial Managers oversee the operational aspects of clinical trials, ensuring efficiency and compliance. This course can provide a strong foundation for this role by covering advanced operational skills, including sample size calculation, data monitoring, and reporting results. The course also addresses the role of the analyst throughout the trial process, giving Clinical Trial Managers a comprehensive understanding of the analytical aspects of clinical research.
Medical Writer
Medical Writer
Medical Writers are responsible for effectively communicating clinical trial results to various audiences. This course can provide valuable training for this role by covering the best practices for reporting results in both journal publications and data monitoring reports. The focus on skilled communication will help Medical Writers present complex scientific information clearly and accurately.
Statistician
Statistician
Statisticians apply statistical methods to analyze and interpret data. This course can provide valuable training for this role by covering advanced operational skills in clinical trial design and monitoring. The course's focus on sample size calculation, data monitoring techniques, and reporting results will help Statisticians contribute effectively to the design, analysis, and reporting of clinical trials.
Data Analyst
Data Analyst
Data Analysts play a significant role in analyzing and interpreting data from clinical trials. This course can enhance the skills needed for this role by providing advanced training in statistical methods for monitoring trial safety, integrity, and efficacy. The course also covers the role of analysts throughout the trial process, helping Data Analysts develop a comprehensive understanding of clinical trial operations.
Clinical Research Associate
Clinical Research Associate
A Clinical Research Associate (CRA) plays a crucial role in managing and monitoring clinical trials, ensuring adherence to protocols and regulations. This course can provide valuable knowledge and skills for this role, covering aspects such as sample size calculation, data monitoring techniques, and reporting results. By understanding these operational functions, CRAs can effectively contribute to the successful execution and analysis of clinical trials.
Biostatistician
Biostatistician
A Biostatistician provides essential statistical expertise for clinical trials and other research projects, ensuring the validity and reliability of data. This course can help build a foundation for this role by providing advanced operational skills in designing and monitoring clinical trials. The course's focus on sample size calculation, statistical methods for monitoring safety, integrity, and efficacy, and reporting results will be valuable for those seeking to enter or advance in this field.
Quality Assurance Associate
Quality Assurance Associate
Quality Assurance Associates ensure the accuracy and completeness of clinical trial data. This course can provide valuable knowledge and skills for this role, covering statistical methods for monitoring trial data quality and integrity. The focus on data monitoring techniques will help Quality Assurance Associates identify and address potential data issues, contributing to the reliability of clinical trial results.
Epidemiologist
Epidemiologist
Epidemiologists investigate the causes and patterns of health and disease in populations. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on sample size calculation and data monitoring techniques can help Epidemiologists assess the validity and reliability of clinical trial data.
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Regulatory Affairs Specialists ensure that clinical trials comply with regulatory guidelines. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on sample size calculation and data monitoring techniques can help Regulatory Affairs Specialists assess the validity and reliability of clinical trial data.
Project Manager
Project Manager
Project Managers oversee the planning, execution, and closing of projects, including clinical trials. This course may be useful for this role by providing an understanding of the advanced operational skills involved in clinical trial design and monitoring. The course's focus on sample size calculation, data monitoring techniques, and reporting results can help Project Managers effectively plan and execute clinical trials.
Healthcare Consultant
Healthcare Consultant
Healthcare Consultants provide advice and guidance to healthcare organizations. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on sample size calculation and data monitoring techniques can help Healthcare Consultants assess the validity and reliability of clinical trial data.
Medical Science Liaison
Medical Science Liaison
Medical Science Liaisons provide scientific and medical information to healthcare professionals. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on reporting results can help Medical Science Liaisons effectively communicate clinical trial findings to healthcare professionals.
Pharmacist
Pharmacist
Pharmacists dispense and manage medications, and provide patient counseling. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on reporting results can help Pharmacists evaluate the efficacy and safety of new medications.
Physician
Physician
Physicians diagnose and treat diseases. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on reporting results can help Physicians evaluate the efficacy and safety of new treatments.
Nurse
Nurse
Nurses provide care to patients in a variety of settings. This course may be useful for this role by providing an understanding of the statistical methods used in clinical trial design and monitoring. The course's focus on reporting results can help Nurses evaluate the efficacy and safety of new treatments.
For more career information including salaries, visit:
OpenCourser.com/course/pyj02g/clinical
Reading list
We've selected six 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
Clinical Trials Analysis, Monitoring, and Presentation.
This textbook provides an extensive overview of the design, conduct, and analysis of clinical trials. It covers a wide range of topics, including principles of clinical trial design, methods for calculating sample size, statistical methods for analyzing clinical trial data, and ethical considerations in clinical research.
Save
Provides a comprehensive overview of the design, conduct, and analysis of clinical trials. It valuable resource for anyone involved in the planning or execution of clinical trials.
Provides a detailed discussion of statistical methods used in clinical trials. It valuable resource for anyone interested in learning more about the statistical aspects of clinical trials.
This textbook provides a comprehensive overview of the design of clinical trials. It covers a wide range of topics, including principles of clinical trial design, methods for calculating sample size, and the different types of clinical trials.
Save
Provides a practical guide to data monitoring in clinical trials. It covers a wide range of topics, including the role of the data monitoring committee, the different types of data monitoring that can be conducted, and the statistical methods that are used.
Save
Provides a detailed discussion of Bayesian methods for clinical trials. It valuable resource for anyone interested in learning more about the use of Bayesian methods in clinical trials.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/pyj02g/clinical
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Effort
4 weeks, 1-2 hours per week
Level
Introductory
Via
Coursera
Institution
Johns Hopkins University
Instructors
Janet Holbrook, PhD, MPH
Elizabeth A. Sugar, PhD
David M. Shade, JD
Language
English
Transcripts
Español
Français
Português
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中文
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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 (viewing)
- Clinical Trials Management and Advanced Operations
- Design and Conduct of Clinical Trials
- Clinical Trials Data Management and Quality Assurance
Good to know
Teaches applied methods for designing advanced clinical trials, ensuring reliable data and integrity
Covers complex statistical methods for monitoring and evaluating clinical trials, ensuring data accuracy and validity
Developed by esteemed instructors with extensive experience in clinical trial design and analysis
Provides practical guidance on reporting results, ensuring clear and effective communication of findings
Delves into advanced topics like simulations and Bayesian statistics, expanding learners' analytical toolkit
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