Data Sciences in Pharma - Patient Centered Outcomes Research

Zum Labor Day gibt es bei Coursera Plus Rabatte von über 70 $. Sparen Sie 3 Monate lang 40 %.

kurs ist nicht verfügbar in Deutsch (Deutschland)

Wir übersetzen es in weitere Sprachen. Sehen Sie sich die Sprachen an, die wir anbieten.

Data Sciences in Pharma - Patient Centered Outcomes Research

Dozent: Susanne Clinch

3.123 bereits angemeldet

Bei Mehr erfahren enthalten

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

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

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

Wichtige Details

Zertifikat zur Vorlage

Zu Ihrem LinkedIn-Profil hinzufügen

Bewertungen

12 Aufgaben

Unterrichtet in Englisch

Flexibler Zeitplan

In Ihrem eigenen Lerntempo lernen

Erfahren Sie, wie Mitarbeiter führender Unternehmen gefragte Kompetenzen erwerben.

Weitere Informationen zu Coursera für Unternehmen

Logos von Petrobras, TATA, Danone, Capgemini, P&G und L'Oreal

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

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

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

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

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

Dozent

Lehrkraftbewertungen

(6 Bewertungen)

Susanne Clinch

Genentech

1 Kurs3.123 Lernende

von

Genentech

Mehr von Data Analysis entdecken

Genentech
Data Science with Real World Data in Pharma
Kurs
Coursera
Basics of Healthcare Data Analytics: Boost Patient Outcomes
Spezialisierung
Status: Kostenloser Testzeitraum
University of Copenhagen
Patient Perspectives on Medications: Qualitative Interviews
Kurs
Kategorie: Kostenlos
University of Glasgow
Introduction to the Pharmaceutical Industry
Kurs
Kategorie: Vorschau

Warum entscheiden sich Menschen für Coursera für ihre Karriere?

Felipe M.

Lernender seit 2018

„Es ist eine großartige Erfahrung, in meinem eigenen Tempo zu lernen. Ich kann lernen, wenn ich Zeit und Nerven dazu habe.“

Jennifer J.

Lernender seit 2020

„Bei einem spannenden neuen Projekt konnte ich die neuen Kenntnisse und Kompetenzen aus den Kursen direkt bei der Arbeit anwenden.“

Larry W.

Lernender seit 2021

„Wenn mir Kurse zu Themen fehlen, die meine Universität nicht anbietet, ist Coursera mit die beste Alternative.“

Chaitanya A.

„Man lernt nicht nur, um bei der Arbeit besser zu werden. Es geht noch um viel mehr. Bei Coursera kann ich ohne Grenzen lernen.“

Nutzen Sie mit unserem Labor-Day-Angebot mehr als 10.000 Programme
Coursera Plus abonnieren
Beginnen Sie mit einfachen Einsparungsmöglichkeiten für hart arbeitende Teams
Sparen Sie heute 30 %

Häufig gestellte Fragen

To access course materials, assignments, and earn a Certificate, you'll need to purchase the Certificate experience when you enroll in a course. Eligible learners may also have the option to start with a Free Trial. Some courses may also offer a Full Course, No Certificate option. This lets you access course materials, submit required assessments, and receive a final grade, but you won't be able to earn or purchase a Certificate.

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.

Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.