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.
Data Sciences in Pharma - Patient Centered Outcomes Research
Data Sciences in Pharma - Patient Centered Outcomes Research
Taught in English
Intermediate level
Recommended experience
8 hours to complete
3 weeks at 2 hours a week
Flexible schedule
Learn at your own pace
What you'll learn
How patient experience data is used in the drug lifecycle
Developing a patient-centric measurement strategy and using qualitative and quantitative patient experience data as evidence in drug development
Common clinical outcome assessment outputs and considerations when interpreting clinical outcome assessment data
Skills you'll gain
Details to know
Shareable certificate
Add to your LinkedIn profile
Recently updated!
May 2024
Assessments
12 assignments
See how employees at top companies are mastering in-demand skills
Earn a career certificate
Add this credential to your LinkedIn profile, resume, or CV
Share it on social media and in your performance review
There are 4 modules in this course
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
What's included
6 videos3 assignments1 plugin
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
What's included
5 videos2 readings3 assignments
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
What's included
11 videos1 reading3 assignments
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
What's included
7 videos2 readings3 assignments
Instructor
Offered by
Recommended if you're interested in Data Analysis
University of California San Diego
Coursera Instructor Network
The State University of New York
Coursera Instructor Network
Why people choose Coursera for their career
Felipe M.
Learner since 2018
"To be able to take courses at my own pace and rhythm has been an amazing experience. I can learn whenever it fits my schedule and mood."
Jennifer J.
Learner since 2020
"I directly applied the concepts and skills I learned from my courses to an exciting new project at work."
Larry W.
Learner since 2021
"When I need courses on topics that my university doesn't offer, Coursera is one of the best places to go."
Chaitanya A.
"Learning isn't just about being better at your job: it's so much more than that. Coursera allows me to learn without limits."
New to Data Analysis? Start here.
Open new doors with Coursera Plus
Unlimited access to 7,000+ world-class courses, hands-on projects, and job-ready certificate programs - all included in your subscription
Advance your career with an online degree
Earn a degree from world-class universities - 100% online
Join over 3,400 global companies that choose Coursera for Business
Upskill your employees to excel in the digital economy
Frequently asked questions
Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
The course may not offer an audit option. You can try a Free Trial instead, or apply for Financial Aid.
The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.
You will be eligible for a full refund until two weeks after your payment date, or (for courses that have just launched) until two weeks after the first session of the course begins, whichever is later. You cannot receive a refund once you’ve earned a Course Certificate, even if you complete the course within the two-week refund period. See our full refund policy.