Data Sciences in Pharma - Patient Centered Outcomes Research

Data Sciences in Pharma - Patient Centered Outcomes Research

Instructor: Susanne Clinch

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

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Assessments

12 assignments

Taught in English

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There are 4 modules in this course

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.

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

6 videosTotal 21 minutes

New Video3 minutesPreview module
1. Lesson introduction0 minutes
2. Describe what a COA is4 minutes
3. How COA evidence fits into the drug development process2 minutes
4. External environment for COA science4 minutes
A background to Patient Experience Data6 minutes

3 assignmentsTotal 40 minutes

Module 1 assignment30 minutes
An introduction to Clinical Outcome Assessments (COAs)5 minutes
A background to Patient Experience Data and patient focussed drug development5 minutes

1 pluginTotal 94 minutes

An overview from FDA on Patient Focussed Drug Development - First 94 minutes only94 minutes

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

5 videosTotal 35 minutes

What qualitative evidence is needed by health authorities?8 minutesPreview module
Steps 1 and 2: Qualitative literature reviews and Qualitative concept elicitation6 minutes
Steps 3 and 4: Developing a disease conceptual model and reviewing existing COAs8 minutes
Step 5: Adapt or develop a measure and conceptual frameworks4 minutes
Step 6 and 7: Cognitively debriefing a new instrument and psychometric properties7 minutes

2 readingsTotal 60 minutes

FDA PFDD guidance 2 - Methods to Identify What Is Important to Patients30 minutes
Clinical Outcome Assessments: Conceptual Foundation–Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force30 minutes

3 assignmentsTotal 41 minutes

Module 2 assignment30 minutes
An introduction to Clinical Outcome Assessments (COAs)6 minutes
Understanding the steps involved in developing, selecting and modifying COAs5 minutes

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

11 videosTotal 48 minutes

1. Introduction to the lesson0 minutesPreview module
2. What is psychometrics and why is it important?2 minutes
3. Classical test theory (CTT)4 minutes
4. Item response theory (IRT)6 minutes
5. CTT vs IRT2 minutes
6. Example setup and analysis plans2 minutes
7. Examples of analyses6 minutes
1. The value of establishing meaningful change in a COA3 minutes
2. Approaches to establishing meaningful change in a COA3 minutes
3. Primary and supportive methods for establishing meaningful change3 minutes
4. An example of establishing meaningful change in Alzheimer's disease12 minutes

1 readingTotal 30 minutes

Development of the SMA independence scale–upper limb module (SMAIS–ULM): A novel scale for individuals with Type 2 and non-ambulant Type 3 SMA30 minutes

3 assignmentsTotal 40 minutes

Module 3 assignment30 minutes
Understanding psychometrics in COA development5 minutes
COAs - establishing and interpreting meaningful change5 minutes

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

7 videosTotal 26 minutes

1. Lesson introduction1 minutePreview module
2. PRO-CTCAE background and context3 minutes
3. PRO-CTCAE items and scoring5 minutes
4. PRO-CTCAE item selection3 minutes
5. Reconciliation of PRO-CTCAE items3 minutes
6. PRO-CTCAE Research examples3 minutes
Interpreting and summarizing COA data in Clinical Study Reports7 minutes

2 readingsTotal 60 minutes

Symptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting in Three Randomized Trials30 minutes
FDA PFDD draft guidance 4 on Incorporating Clinical Outcome Assessments Into Endpoints For Regulatory Decision-Making30 minutes