Data Sciences in Pharma - Patient Centered Outcomes Research

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Data Sciences in Pharma - Patient Centered Outcomes Research

Dozent: Susanne Clinch

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4 Module

Verschaffen Sie sich einen Einblick in ein Thema und lernen Sie die Grundlagen.

23 Bewertungen

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9 Stunden zu vervollständigen

Flexibler Zeitplan

In Ihrem eigenen Lerntempo lernen

4 Module

Verschaffen Sie sich einen Einblick in ein Thema und lernen Sie die Grundlagen.

23 Bewertungen

Stufe Mittel

Empfohlene Erfahrung

9 Stunden zu vervollständigen

Flexibler Zeitplan

In Ihrem eigenen Lerntempo lernen

Was Sie lernen werden

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

Kompetenzen, die Sie erwerben

Kategorie: Oncology
Kategorie: Data Science
Kategorie: Clinical Trials
Kategorie: Psychosocial Assessments
Kategorie: Drug Development
Kategorie: Pharmaceutical Terminology
Kategorie: Quantitative Research
Kategorie: Clinical Assessment
Kategorie: Clinical Research
Kategorie: Statistical Analysis
Kategorie: Pharmaceuticals
Kategorie: Patient Observation
Kategorie: Psychological Evaluations
Kategorie: Data Literacy
Kategorie: Statistical Methods
Kategorie: Patient Evaluation
Kategorie: Patient-centered Care

Wichtige Details

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12 Aufgaben

Unterrichtet in Englisch

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In diesem Kurs gibt es 4 Module

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

Das ist alles enthalten

6 Videos3 Aufgaben1 Plug-in

6 VideosInsgesamt 22 Minuten

New Video3 Minuten
1. Lesson introduction1 Minute
2. Describe what a COA is5 Minuten
3. How COA evidence fits into the drug development process3 Minuten
4. External environment for COA science4 Minuten
A background to Patient Experience Data6 Minuten

3 AufgabenInsgesamt 40 Minuten

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

1 Plug-inInsgesamt 94 Minuten

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

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

Das ist alles enthalten

5 Videos2 Lektüren3 Aufgaben

5 VideosInsgesamt 36 Minuten

What qualitative evidence is needed by health authorities?9 Minuten
Steps 1 and 2: Qualitative literature reviews and Qualitative concept elicitation6 Minuten
Steps 3 and 4: Developing a disease conceptual model and reviewing existing COAs8 Minuten
Step 5: Adapt or develop a measure and conceptual frameworks5 Minuten
Step 6 and 7: Cognitively debriefing a new instrument and psychometric properties7 Minuten

2 LektürenInsgesamt 60 Minuten

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

3 AufgabenInsgesamt 41 Minuten

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

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

Das ist alles enthalten

11 Videos1 Lektüre3 Aufgaben

11 VideosInsgesamt 48 Minuten

1. Introduction to the lesson1 Minute
2. What is psychometrics and why is it important?2 Minuten
3. Classical test theory (CTT)5 Minuten
4. Item response theory (IRT)7 Minuten
5. CTT vs IRT2 Minuten
6. Example setup and analysis plans3 Minuten
7. Examples of analyses7 Minuten
1. The value of establishing meaningful change in a COA3 Minuten
2. Approaches to establishing meaningful change in a COA3 Minuten
3. Primary and supportive methods for establishing meaningful change4 Minuten
4. An example of establishing meaningful change in Alzheimer's disease12 Minuten

1 LektüreInsgesamt 30 Minuten

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 Minuten

3 AufgabenInsgesamt 40 Minuten

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

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

Das ist alles enthalten

7 Videos2 Lektüren3 Aufgaben

7 VideosInsgesamt 27 Minuten

1. Lesson introduction1 Minute
2. PRO-CTCAE background and context3 Minuten
3. PRO-CTCAE items and scoring5 Minuten
4. PRO-CTCAE item selection3 Minuten
5. Reconciliation of PRO-CTCAE items3 Minuten
6. PRO-CTCAE Research examples3 Minuten
Interpreting and summarizing COA data in Clinical Study Reports8 Minuten

2 LektürenInsgesamt 60 Minuten

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

3 AufgabenInsgesamt 42 Minuten

Module 4 assignment30 Minuten
Measuring treatment related tolerability via PROs5 Minuten
Common COA data outputs and considerations when interpreting COA data7 Minuten

Dozent

Lehrkraftbewertungen

(6 Bewertungen)

Susanne Clinch

Genentech

1 Kurs3.002 Lernende

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