Related Experiment Video
Updated: Feb 2, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
The importance of patient-reported outcomes in clinical trials and strategies for future optimization
Rebecca Mercieca-Bebber1, Madeleine T King2,3, Melanie J Calvert4,5
1NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia, rebecca.mercieca@sydney.edu.au; michael.friedlander@health.nsw.gov.au.
Abstract:
Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary endpoints and are increasingly recognized by regulators, clinicians, and patients as valuable tools to collect patient-centered data. PROs provide unique information on the impact of a medical condition and its treatment from the patient's perspective; therefore, PROs can be included in clinical trials to ensure the impact of a trial intervention is comprehensively assessed. This review first discusses examples of how PRO endpoints have added value to clinical trial interpretation. Second, it describes the problems with current practices in designing, implementing, and reporting PRO studies, and how these problems may be addressed by complying with guidance for protocol development, selecting appropriate PRO measures to match clinically motivated PRO hypotheses, minimizing the rates of avoidable missing PRO data, analyzing and interpreting PRO data, and transparently reporting PRO findings.
More Related Videos
05:16Characterizing Exon Skipping Efficiency in DMD Patient Samples in Clinical Trials of Antisense Oligonucleotides
Published on: May 7, 2020
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Statistical Software for Data Analysis and Clinical Trials
Data Reporting and Recording
Trial and Error and Algorithm
Predicting Reaction Outcomes