Data Sciences in Pharma - Patient Centered Outcomes Research

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Data Sciences in Pharma - Patient Centered Outcomes Research

Instructeur : Susanne Clinch

2 940 déjà inscrits

Inclus avec

4 modules

Obtenez un aperçu d'un sujet et apprenez les principes fondamentaux.

22 avis

niveau Intermédiaire

Expérience recommandée

9 heures à compléter

Planning flexible

Apprenez à votre propre rythme

4 modules

Obtenez un aperçu d'un sujet et apprenez les principes fondamentaux.

22 avis

niveau Intermédiaire

Expérience recommandée

9 heures à compléter

Planning flexible

Apprenez à votre propre rythme

Ce que vous apprendrez

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

Compétences que vous acquerrez

Catégorie : Statistical Analysis
Catégorie : Clinical Research
Catégorie : Drug Development
Catégorie : Data Literacy
Catégorie : Pharmaceutical Terminology
Catégorie : Data Science
Catégorie : Clinical Trials
Catégorie : Quantitative Research
Catégorie : Patient Evaluation
Catégorie : Statistical Methods
Catégorie : Clinical Assessment
Catégorie : Patient-centered Care

Détails à connaître

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Évaluations

12 devoirs

Enseigné en Anglais

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Il y a 4 modules dans ce cours

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

Inclus

6 vidéos3 devoirs1 plugin

6 vidéos Total 22 minutes

New Video 3 minutes
1. Lesson introduction 1 minute
2. Describe what a COA is 5 minutes
3. How COA evidence fits into the drug development process 3 minutes
4. External environment for COA science 4 minutes
A background to Patient Experience Data 6 minutes

3 devoirs Total 40 minutes

An introduction to Clinical Outcome Assessments (COAs) 5 minutes
A background to Patient Experience Data and patient focussed drug development 5 minutes
Module 1 assignment 30 minutes

1 plugin Total 94 minutes

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

Inclus

5 vidéos2 lectures3 devoirs

5 vidéos Total 36 minutes

What qualitative evidence is needed by health authorities? 9 minutes
Steps 1 and 2: Qualitative literature reviews and Qualitative concept elicitation 6 minutes
Steps 3 and 4: Developing a disease conceptual model and reviewing existing COAs 8 minutes
Step 5: Adapt or develop a measure and conceptual frameworks 5 minutes
Step 6 and 7: Cognitively debriefing a new instrument and psychometric properties 7 minutes

2 lectures Total 60 minutes

FDA PFDD guidance 2 - Methods to Identify What Is Important to Patients 30 minutes
Clinical Outcome Assessments: Conceptual Foundation–Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force 30 minutes

3 devoirs Total 41 minutes

An introduction to Clinical Outcome Assessments (COAs) 6 minutes
Understanding the steps involved in developing, selecting and modifying COAs 5 minutes
Module 2 assignment 30 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

Inclus

11 vidéos1 lecture3 devoirs

11 vidéos Total 48 minutes

1. Introduction to the lesson 1 minute
2. What is psychometrics and why is it important? 2 minutes
3. Classical test theory (CTT) 5 minutes
4. Item response theory (IRT) 7 minutes
5. CTT vs IRT 2 minutes
6. Example setup and analysis plans 3 minutes
7. Examples of analyses 7 minutes
1. The value of establishing meaningful change in a COA 3 minutes
2. Approaches to establishing meaningful change in a COA 3 minutes
3. Primary and supportive methods for establishing meaningful change 4 minutes
4. An example of establishing meaningful change in Alzheimer's disease 12 minutes

1 lecture Total 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 SMA 30 minutes

3 devoirs Total 40 minutes

Understanding psychometrics in COA development 5 minutes
COAs - establishing and interpreting meaningful change 5 minutes
Module 3 assignment 30 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

Inclus

7 vidéos2 lectures3 devoirs

7 vidéos Total 27 minutes

1. Lesson introduction 1 minute
2. PRO-CTCAE background and context 3 minutes
3. PRO-CTCAE items and scoring 5 minutes
4. PRO-CTCAE item selection 3 minutes
5. Reconciliation of PRO-CTCAE items 3 minutes
6. PRO-CTCAE Research examples 3 minutes
Interpreting and summarizing COA data in Clinical Study Reports 8 minutes

2 lectures Total 60 minutes

Symptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting in Three Randomized Trials 30 minutes
FDA PFDD draft guidance 4 on Incorporating Clinical Outcome Assessments Into Endpoints For Regulatory Decision-Making 30 minutes

3 devoirs Total 42 minutes

Measuring treatment related tolerability via PROs 5 minutes
Common COA data outputs and considerations when interpreting COA data 7 minutes
Module 4 assignment 30 minutes

Instructeur

Évaluations de l’enseignant

(6 évaluations)

Susanne Clinch

Genentech

1 Cours 2 940 apprenants

Offert par

Genentech

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