Data Sciences in Pharma - Patient Centered Outcomes Research

Genentech via Coursera

Go to Course: https://www.coursera.org/learn/data-science-patient-centered-research-in-pharma-industry

Introduction

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

Syllabus

An introduction to clinical outcome assessments and patient experience data

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

How is a Clinical Outcome Assessment selected, developed or modified and validated? -Qualitative research

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

How is a Clinical Outcome Assessment selected, developed or modified and validated? -Quantitative research

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

Common COA applications in clinical trials

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