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Data Sciences in Pharma - Patient Centered Outcomes Research · LearnSpace
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Data Sciences in Pharma - Patient Centered Outcomes Research

Курс от Genentech
Средний≈ 9 чАнглийский
О курсеНавыкиПрограммаПреподаватели

О курсе

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. No experience in the pharmaceutical industry is needed for this course, but it is beneficial. This is an introductory course so an interest in qualitative and quantitative data and some basic knowledge in data analytics and statistics will be helpful for some lessons but is not required.

Навыки, которые вы освоите

Patient-centered CareDrug DevelopmentClinical AssessmentPsychological EvaluationsStatistical MethodsData ScienceQuantitative ResearchOncologyPsychosocial AssessmentsClinical TrialsData LiteracyClinical ResearchPharmaceuticalsStatistical AnalysisPatient ObservationPatient EvaluationPharmaceutical Terminology

Программа курса

4 модулей · 47 учебных материалов

01An introduction to clinical outcome assessments and patient experience data10 материалов

An introduction to Clinical Outcome Assessments (COAs)

New VideoВидео1. Lesson introductionВидео2. Describe what a COA isВидео3. How COA evidence fits into the drug development processВидео4. External environment for COA science

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Susanne Clinch

Преподаватель курса

Data Sciences in Pharma - Patient Centered Outcomes Research
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Обучение на Coursera

≈ 9 ч

4 модулей

Язык: Английский

Субтитры: Венгерский

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Видео
An introduction to Clinical Outcome Assessments (COAs)Задание

A background to Patient Experience Data and patient focussed drug development

A background to Patient Experience DataВидеоAn overview from FDA on Patient Focussed Drug Development - First 94 minutes onlyPLUGINA background to Patient Experience Data and patient focussed drug developmentЗаданиеModule 1 assignmentЗадание
02How is a Clinical Outcome Assessment selected, developed or modified and validated? -Qualitative research10 материалов

Understanding the importance of qualitative data in COA selection and development

What qualitative evidence is needed by health authorities?ВидеоFDA PFDD guidance 2 - Methods to Identify What Is Important to PatientsЧтениеAn introduction to Clinical Outcome Assessments (COAs)Задание

Understanding the steps involved in developing, selecting and modifying COAs

Steps 1 and 2: Qualitative literature reviews and Qualitative concept elicitationВидеоSteps 3 and 4: Developing a disease conceptual model and reviewing existing COAsВидеоStep 5: Adapt or develop a measure and conceptual frameworksВидеоStep 6 and 7: Cognitively debriefing a new instrument and psychometric propertiesВидеоClinical Outcome Assessments: Conceptual Foundation–Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task ForceЧтениеUnderstanding the steps involved in developing, selecting and modifying COAsЗаданиеModule 2 assignmentЗадание
03How is a Clinical Outcome Assessment selected, developed or modified and validated? -Quantitative research15 материалов

Understanding psychometrics in COA development

1. Introduction to the lessonВидео2. What is psychometrics and why is it important?Видео3. Classical test theory (CTT)Видео4. Item response theory (IRT)Видео5. CTT vs IRTВидео6. Example setup and analysis plansВидео7. Examples of analysesВидеоDevelopment of the SMA independence scale–upper limb module (SMAIS–ULM): A novel scale for individuals with Type 2 and non-ambulant Type 3 SMAЧтениеUnderstanding psychometrics in COA developmentЗадание

COAs - establishing and interpreting meaningful change

1. The value of establishing meaningful change in a COAВидео2. Approaches to establishing meaningful change in a COAВидео3. Primary and supportive methods for establishing meaningful changeВидео4. An example of establishing meaningful change in Alzheimer's diseaseВидеоCOAs - establishing and interpreting meaningful changeЗаданиеModule 3 assignmentЗадание
04Common COA applications in clinical trials12 материалов

Measuring treatment related tolerability via PROs

1. Lesson introductionВидео2. PRO-CTCAE background and contextВидео3. PRO-CTCAE items and scoringВидео4. PRO-CTCAE item selectionВидео5. Reconciliation of PRO-CTCAE itemsВидео6. PRO-CTCAE Research examplesВидеоSymptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting in Three Randomized TrialsЧтениеMeasuring treatment related tolerability via PROsЗадание

Common COA data outputs and considerations when interpreting COA data

Interpreting and summarizing COA data in Clinical Study ReportsВидеоFDA PFDD draft guidance 4 on Incorporating Clinical Outcome Assessments Into Endpoints For Regulatory Decision-MakingЧтениеCommon COA data outputs and considerations when interpreting COA dataЗаданиеModule 4 assignmentЗадание