Data Sciences in Pharma - Patient Centered Outcomes Research

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Data Sciences in Pharma - Patient Centered Outcomes Research

位教师：Susanne Clinch

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4个模块

深入了解一个主题并学习基础知识。

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9 小时完成

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自行安排学习进度

4个模块

深入了解一个主题并学习基础知识。

22 条评论

中级等级

推荐体验

9 小时完成

灵活的计划

自行安排学习进度

您将学到什么

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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作业

12 项作业

授课语言：英语（English）

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该课程共有4个模块

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

涵盖的内容

6个视频3个作业1个插件

6个视频总计22分钟

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

3个作业总计40分钟

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

1个插件总计94分钟

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

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

涵盖的内容

5个视频2篇阅读材料3个作业

5个视频总计36分钟

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

2篇阅读材料总计60分钟

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

3个作业总计41分钟

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

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

涵盖的内容

11个视频1篇阅读材料3个作业

11个视频总计48分钟

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

1篇阅读材料总计30分钟

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分钟

3个作业总计40分钟

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

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

涵盖的内容

7个视频2篇阅读材料3个作业

7个视频总计27分钟

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

2篇阅读材料总计60分钟

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

3个作业总计42分钟

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

位教师

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Susanne Clinch

Genentech

1 门课程 2,943 名学生

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Genentech

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