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Susanne Clinch
The course is targeted toward people who are interested in how patient experience data and clinical outcome assessment (COA) data can be used as evidence across drug development, in the pharmaceutical industry. By the end of the course you will better understand how this data is collected and analysed to evidence how patients feel, function or survive in the context of a clinical trial. More specifically, the course will cover: i) a background to COAs; ii) a background to patient experience data; iii) how to select, develop/modify and validate COAs using qualitative data (a) and psychometrics (b); iv) interpreting data on a COA; v) measuring treatment related tolerability via patient reported outcomes; vi) Common COA data outputs.
Read more
The course is targeted toward people who are interested in how patient experience data and clinical outcome assessment (COA) data can be used as evidence across drug development, in the pharmaceutical industry. By the end of the course you will better understand how this data is collected and analysed to evidence how patients feel, function or survive in the context of a clinical trial. More specifically, the course will cover: i) a background to COAs; ii) a background to patient experience data; iii) how to select, develop/modify and validate COAs using qualitative data (a) and psychometrics (b); iv) interpreting data on a COA; v) measuring treatment related tolerability via patient reported outcomes; vi) Common COA data outputs.
Read more
The course is targeted toward people who are interested in how patient experience data and clinical outcome assessment (COA) data can be used as evidence across drug development, in the pharmaceutical industry. By the end of the course you will better understand how this data is collected and analysed to evidence how patients feel, function or survive in the context of a clinical trial. More specifically, the course will cover: i) a background to COAs; ii) a background to patient experience data; iii) how to select, develop/modify and validate COAs using qualitative data (a) and psychometrics (b); iv) interpreting data on a COA; v) measuring treatment related tolerability via patient reported outcomes; vi) Common COA data outputs.
No experience in the pharmaceutical industry is needed for this course, but it is beneficial. This is an introductory course so an interest in qualitative and quantitative data and some basic knowledge in data analytics and statistics will be helpful for some lessons but is not required.
Register for this course and see more details by visiting:
OpenCourser.com/course/zixpku/data
What's inside
Syllabus
An introduction to clinical outcome assessments and patient experience data
This module will cover a background of clinical outcome assessments (COAs) and patient experience data, what they are and what they consist of, how this data fits into drug development and the importance of this data as evidence to the external environement (such as health authorities) across the drug lifecycle
Read more
Syllabus
An introduction to clinical outcome assessments and patient experience data
This module will cover a background of clinical outcome assessments (COAs) and patient experience data, what they are and what they consist of, how this data fits into drug development and the importance of this data as evidence to the external environement (such as health authorities) across the drug lifecycle
Read more
How is a Clinical Outcome Assessment selected, developed or modified and validated?
-Qualitative research
This Module will discuss ways in which qualitative research is used to select, develop, modify or validate a COA. The amount of qualitative research study teams need to conduct can depend on how much qualitative research for the concept of interest in the context of use is already publically available. Qualitative research is often an initial step health authorities such as FDA mandate when they evaluate the suitability of existing and newly developed COAs selected for a clinical trial
How is a Clinical Outcome Assessment selected, developed or modified and validated?
-Quantitative research
This Module will discuss some of the common quantitative methods used when selecting, developing, modifying and validating a COA. This will include a background to psychometrics and the different properties that are considered for classical test therory and item response theory. It will also touch on the important topic of evaluating change in a COA, what that change means and methods to establish what threshold in the COA of interest would be described as meaningful from the patient's point of view
Common COA applications in clinical trials
This module will provide an understanding of a how patient reported outcomes (PROs) are used to measure treatment related tolerability, with a focus on a commonly used measure called the PRO-CTCAE as well as common COA outputs and considerations when interpreting COA data
Good to know
Good to know
Know what's good ,
what to watch for , and
possible dealbreakers
The course is tailored towards informing how health authorities evaluate a COA
Taught by instructors who are recognized for their work in this field
Provides a foundation on patient experience data and clinical outcome assessments
Covers qualitative and quantitative methods used in COA selections
Explores the use of patient reported outcomes in measuring treatment related tolerability
Requires some basic knowledge in data analytics, but no experience in the pharmaceutical industry
Save this course
Save Data Sciences in Pharma - Patient Centered Outcomes Research to your list so you can find it easily later:
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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 Data Sciences in Pharma - Patient Centered Outcomes Research with these
activities:
Review Key Concepts and Definitions
Show steps
This review will help you build a solid foundation for understanding the concepts covered in the course.
Show steps
-
Review the course syllabus and identify key concepts and definitions.
-
Create a glossary of terms and definitions.
-
Read relevant sections of the textbook or other introductory materials.
Refresher on Statistical Methods
Show steps
Brush up on statistical methods to strengthen your foundation knowledge in this course. Topics like data analysis, hypothesis testing, and regression models can be found in most introductory statistics textbooks.
Browse courses on
Statistical Methods
Show steps
-
Review fundamental statistical concepts: data types, sampling, probability distributions, and descriptive statistics.
-
Study the principles of hypothesis testing: null and alternative hypotheses, errors, type I and type II, and significance levels.
-
Practice data analysis techniques: summarizing, organizing, and interpreting data.
Read 'Fundamentals of Clinical Trials' by Friedman, Furberg, DeMets
Show steps
Gain a comprehensive understanding of clinical trial design and conduct.
Show steps
-
Read the chapters relevant to the course material.
-
Summarize key concepts and methodologies.
-
Apply the knowledge gained to the context of clinical outcome assessments.
12 other activities
Expand to see all activities and additional details
Show all 15 activities
Background research on Patient Reported Outcomes (PROs)
Show steps
Review foundational concepts to ensure a strong base before embarking on the course.
Show steps
-
Review journal articles on the development and use of PROs.
-
Explore the FDA website for guidance documents on PROs.
-
Attend a webinar or online presentation on the use of PROs in clinical trials.
Understand Psychometric Properties
Show steps
These tutorials will provide you with the necessary background in psychometrics to evaluate the validity of COAs.
Browse courses on
Psychometrics
Show steps
-
Find online tutorials or courses on psychometrics.
-
Complete the tutorials and practice exercises.
-
Apply psychometric principles to evaluate COAs in the context of clinical trials.
Form a study group
Show steps
Foster collaboration, active recall, and deeper understanding of course material with peers.
Show steps
-
Find classmates with complementary skills and interests.
-
Establish a regular meeting schedule and study plan.
-
Take turns leading discussions and sharing insights.
-
Collaborate on practice problems and assignments.
-
Evaluate each other's understanding through quizzes or mock presentations.
Develop a COA Selection Plan
Show steps
This project will give you hands-on experience in selecting and justifying COAs for a specific clinical trial.
Browse courses on
Clinical Trial Design
Show steps
-
Identify a clinical trial scenario and define the research question.
-
Review available COAs and select the most appropriate ones.
-
Develop a plan for collecting and analyzing COA data.
-
Create a presentation or report that outlines your plan.
Explore online tutorials on psychometrics
Show steps
Enhance knowledge of psychometric principles for evaluating clinical outcome assessments.
Browse courses on
Psychometrics
Show steps
-
Identify reputable platforms or organizations offering psychometrics tutorials.
-
Select tutorials that align with the course content and your skill level.
-
Complete the tutorials at your own pace, taking notes and practicing examples.
-
Seek clarification from the course instructor or online forums if needed.
Practice Interpreting COA Data
Show steps
These drills will help you develop the skills needed to interpret and analyze COA data.
Browse courses on
Statistical Analysis
Show steps
-
Find practice datasets with COA data.
-
Use statistical software to analyze the data and interpret the results.
-
Compare your results with those of experts in the field.
Practice interpreting clinical outcome assessment data
Show steps
Develop proficiency in interpreting and analyzing clinical outcome assessment data by engaging in targeted practice exercises.
Browse courses on
Data Interpretation
Show steps
-
Find practice datasets or case studies related to clinical trials.
-
Apply the concepts and methods learned in the course to analyze and interpret the data.
-
Compare your interpretations with expert opinions or published literature.
-
Repeat the process with different datasets to improve your skills.
Participate in a COA Design Challenge
Show steps
This competition will challenge you to design and validate a COA that meets specific criteria.
Browse courses on
Clinical Research
Show steps
-
Find a COA design challenge or competition.
-
Form a team and develop a COA design proposal.
-
Collect and analyze data to validate your COA design.
-
Submit your proposal and compete against other teams.
Develop a patient experience data collection plan
Show steps
Apply course concepts to create a practical plan for gathering patient experience data.
Show steps
-
Identify the specific patient population of interest.
-
Determine the objectives of the data collection.
-
Select appropriate data collection methods (e.g., surveys, interviews, focus groups).
-
Develop a detailed plan for implementing the data collection.
-
Pilot test the data collection plan and make necessary adjustments.
Mentor Junior Researchers
Show steps
Mentoring others can help you solidify your understanding of the course material and develop your leadership skills.
Browse courses on
Mentoring
Show steps
-
Identify junior researchers who are interested in learning about COAs.
-
Provide guidance and support on COA selection, validation, and analysis.
-
Encourage them to participate in research projects and conferences.
Attend a workshop on clinical outcome assessments
Show steps
Engage with experts and practitioners in the field to enhance understanding and gain practical insights.
Show steps
-
Identify industry-recognized workshops aligned with the course content.
-
Register for the workshop and prepare for active participation.
-
Attend the workshop, take notes, and engage in discussions.
-
Follow up with experts or attendees to clarify concepts or explore further opportunities.
Contribute to an open-source COA software project
Show steps
Gain practical experience in working with COA data and contribute to the development of open-source tools.
Browse courses on
Open-Source Software
Show steps
-
Identify open-source projects related to COAs and patient experience data.
-
Review the project documentation and codebase.
-
Identify a specific area where you can contribute your skills.
-
Communicate with the project maintainers and propose your contribution.
-
Implement your contribution and submit a pull request.
Review Key Concepts and Definitions
Show steps
This review will help you build a solid foundation for understanding the concepts covered in the course.
Show steps
Show steps
Show steps
- Review the course syllabus and identify key concepts and definitions.
- Create a glossary of terms and definitions.
- Read relevant sections of the textbook or other introductory materials.
Refresher on Statistical Methods
Show steps
Brush up on statistical methods to strengthen your foundation knowledge in this course. Topics like data analysis, hypothesis testing, and regression models can be found in most introductory statistics textbooks.
Browse courses on
Statistical Methods
Show steps
Show steps
Show steps
- Review fundamental statistical concepts: data types, sampling, probability distributions, and descriptive statistics.
- Study the principles of hypothesis testing: null and alternative hypotheses, errors, type I and type II, and significance levels.
- Practice data analysis techniques: summarizing, organizing, and interpreting data.
Read 'Fundamentals of Clinical Trials' by Friedman, Furberg, DeMets
Show steps
Gain a comprehensive understanding of clinical trial design and conduct.
Show steps
Show steps
Show steps
- Read the chapters relevant to the course material.
- Summarize key concepts and methodologies.
- Apply the knowledge gained to the context of clinical outcome assessments.
12 other activities
Expand to see all activities and additional details
Show all 15 activities
Background research on Patient Reported Outcomes (PROs)
Show steps
Review foundational concepts to ensure a strong base before embarking on the course.
Show steps
Show steps
Show steps
- Review journal articles on the development and use of PROs.
- Explore the FDA website for guidance documents on PROs.
- Attend a webinar or online presentation on the use of PROs in clinical trials.
Understand Psychometric Properties
Show steps
These tutorials will provide you with the necessary background in psychometrics to evaluate the validity of COAs.
Browse courses on
Psychometrics
Show steps
Show steps
Show steps
- Find online tutorials or courses on psychometrics.
- Complete the tutorials and practice exercises.
- Apply psychometric principles to evaluate COAs in the context of clinical trials.
Form a study group
Show steps
Foster collaboration, active recall, and deeper understanding of course material with peers.
Show steps
Show steps
Show steps
- Find classmates with complementary skills and interests.
- Establish a regular meeting schedule and study plan.
- Take turns leading discussions and sharing insights.
- Collaborate on practice problems and assignments.
- Evaluate each other's understanding through quizzes or mock presentations.
Develop a COA Selection Plan
Show steps
This project will give you hands-on experience in selecting and justifying COAs for a specific clinical trial.
Browse courses on
Clinical Trial Design
Show steps
Show steps
Show steps
- Identify a clinical trial scenario and define the research question.
- Review available COAs and select the most appropriate ones.
- Develop a plan for collecting and analyzing COA data.
- Create a presentation or report that outlines your plan.
Explore online tutorials on psychometrics
Show steps
Enhance knowledge of psychometric principles for evaluating clinical outcome assessments.
Browse courses on
Psychometrics
Show steps
Show steps
Show steps
- Identify reputable platforms or organizations offering psychometrics tutorials.
- Select tutorials that align with the course content and your skill level.
- Complete the tutorials at your own pace, taking notes and practicing examples.
- Seek clarification from the course instructor or online forums if needed.
Practice Interpreting COA Data
Show steps
These drills will help you develop the skills needed to interpret and analyze COA data.
Browse courses on
Statistical Analysis
Show steps
Show steps
Show steps
- Find practice datasets with COA data.
- Use statistical software to analyze the data and interpret the results.
- Compare your results with those of experts in the field.
Practice interpreting clinical outcome assessment data
Show steps
Develop proficiency in interpreting and analyzing clinical outcome assessment data by engaging in targeted practice exercises.
Browse courses on
Data Interpretation
Show steps
Show steps
Show steps
- Find practice datasets or case studies related to clinical trials.
- Apply the concepts and methods learned in the course to analyze and interpret the data.
- Compare your interpretations with expert opinions or published literature.
- Repeat the process with different datasets to improve your skills.
Participate in a COA Design Challenge
Show steps
This competition will challenge you to design and validate a COA that meets specific criteria.
Browse courses on
Clinical Research
Show steps
Show steps
Show steps
- Find a COA design challenge or competition.
- Form a team and develop a COA design proposal.
- Collect and analyze data to validate your COA design.
- Submit your proposal and compete against other teams.
Develop a patient experience data collection plan
Show steps
Apply course concepts to create a practical plan for gathering patient experience data.
Show steps
Show steps
Show steps
- Identify the specific patient population of interest.
- Determine the objectives of the data collection.
- Select appropriate data collection methods (e.g., surveys, interviews, focus groups).
- Develop a detailed plan for implementing the data collection.
- Pilot test the data collection plan and make necessary adjustments.
Mentor Junior Researchers
Show steps
Mentoring others can help you solidify your understanding of the course material and develop your leadership skills.
Browse courses on
Mentoring
Show steps
Show steps
Show steps
- Identify junior researchers who are interested in learning about COAs.
- Provide guidance and support on COA selection, validation, and analysis.
- Encourage them to participate in research projects and conferences.
Attend a workshop on clinical outcome assessments
Show steps
Engage with experts and practitioners in the field to enhance understanding and gain practical insights.
Show steps
Show steps
Show steps
- Identify industry-recognized workshops aligned with the course content.
- Register for the workshop and prepare for active participation.
- Attend the workshop, take notes, and engage in discussions.
- Follow up with experts or attendees to clarify concepts or explore further opportunities.
Contribute to an open-source COA software project
Show steps
Gain practical experience in working with COA data and contribute to the development of open-source tools.
Browse courses on
Open-Source Software
Show steps
Show steps
Show steps
- Identify open-source projects related to COAs and patient experience data.
- Review the project documentation and codebase.
- Identify a specific area where you can contribute your skills.
- Communicate with the project maintainers and propose your contribution.
- Implement your contribution and submit a pull request.
Career center
Learners who complete Data Sciences in Pharma - Patient Centered Outcomes Research will develop knowledge and skills
that may be useful to these careers:
For more career information including salaries, visit:
OpenCourser.com/course/zixpku/data
Reading list
We haven't picked any books for this reading list yet.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/zixpku/data
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Effort
4 weeks of study, 2-3 hours/week
Level
Intermediate
Via
Coursera
Institution
Genentech
Instructor
Susanne Clinch
Session
August 19, 2024
- September 23, 2024
Language
English
Good to know
The course is tailored towards informing how health authorities evaluate a COA
Taught by instructors who are recognized for their work in this field
Provides a foundation on patient experience data and clinical outcome assessments
Covers qualitative and quantitative methods used in COA selections
Explores the use of patient reported outcomes in measuring treatment related tolerability
Requires some basic knowledge in data analytics, but no experience in the pharmaceutical industry
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