An Analysis on Prevalence, Success, and Implication of Patient Reported Outcomes in Current and Past Clinical Trials

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Publication Date

11-7-2023

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Presentation: 24:07

Abstract

Patient reported outcomes (PROs) provide critical subjective data on patient wellbeing during clinical trials. These data are gathered without clinician or researcher intervention and offer an unbiased view on patient health status. PROs are collected using questionnaires and include questions ranging from pain and fatigue to depression and stress levels. Due to the relative newness of including patient reported outcomes in clinical trials, guidance is not always clear, and discrepancies arise. The purpose of this capstone was to describe PROs, reveal their importance, understand recurring problems, and postulate solutions to improve their implementation. A scoping literature review from 2015 to 2023 was performed using online databases to find patterns and trends in the analysis and success of PROs. Results from this literature review exposed several shortcomings of the use and success of PROs in clinical trials. A lack in FDA guidance on the collection and in trial remediation of PRO data was revealed. Recurring issues such as lack in response rate and truthfulness of responses were also found. It was concluded that FDA guidance was not all encompassing and could potentially result in a lack of consistency between trials using PRO questionnaires. Resolutions on amending and improving patient response rate and truthfulness were also concluded to be lacking, and potentially leading to bias within clinical trials. Improving FDA guidance to include more stringent guidelines on how to review PRO data within trials and ensuring response rate and the truthfulness of patient answers throughout the trials, can improve the success of PRO data for future studies.

Language

English

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