ISPOR 2024 (International Society for Pharmacoeconomics and Outcomes Research)
Join global healthcare leaders at ISPOR 2024, the leading global conference for health economics and outcomes research (HEOR) between May 5-8 to find out more about the latest healthcare trends. Covering Clinical Outcomes, Patient-Centered Research, AI in HEOR methods, Epidemiology and Public Health and Health Policy and Regulatory, among others. The conference provides opportunities to network with peers, HEOR experts and thought leaders and to discuss how to establish, incentivize, and share value sustainable for health systems, patients, and technology developers. During the conference, Clario eCOA Science’s Jessica Emerson will present two posters. The first is about the Electronic Collection of PRO measures in Dermatology Trials, the second about Compliance and Design Features of Electronic Participant-Reported Dosing Diaries.
Session 1 Information:
Title: Electronic Collection of Patient-Reported Outcome Measures in Dermatology Trials
Author: Jowita Marszewska, MS, Ph.D.
Location: Presenting in poster session 4
Date: Tuesday, May 7, 2024
Time: 3:30 p.m. – 6:30 p.m.
Discussion period: 4:00 p.m. – 5:00 p.m.
Abstract:
Patient-reported outcomes (PROs), such as diaries or questionnaires, can be collected using electronic devices during the course of a clinical trial. Data gathered via ePROs that shows a new medication improves participant’s outcomes, supports regulatory submissions. Impact of a medication on PROs is important in dermatology space because skin diseases affect participants’ lives in a negative way. The aim of this research was to perform a review and analyze the use of ePRO instruments in dermatology trials. 35 dermatology trials were identified in the sample of 506 studies. PRO instruments were characterized by trial phase, endpoint hierarchy, study population, and data collection modality. Our analysis shows that around 30 % of PROs in 35 trials supported primary and/or key secondary outcomes. Tablet was used for PRO data collection during site visits and handheld was utilized for daily data collection. Generally, when dermatology trials utilized PRO instruments, almost 50% of these studies used an electronic diary to collect data.
Session 2 Information:
Title: Compliance and Design Features of Electronic Participant-Reported Dosing Diaries
Location: Presenting in poster session 4
Date: Tuesday, May 7, 2024
Time: 3:30 p.m. – 6:30 p.m.
Discussion period: 4:00 p.m. – 5:00 p.m.
Abstract:
The extent to which participants adhere to prescribed dosing regimens is a critical factor in clinical trials and a regulatory priority. Participant-reported dosing using electronic diaries (eDiaries) is valuable in evaluating drug adherence by providing near-real time data for site monitoring and intervention. We examined electronic dosing diary completion across studies and described design features that can impact data integrity. Data from 16 studies across phases and multiple therapeutic areas were analyzed for content and compliance with dosing eDiaries using Clario’s app. The varied content of these dosing diaries suggests there is a need for more consistency and standardization of requirements to support data quality. The high compliance across studies and over time suggests that eDiaries are a feasible approach for assessing drug adherence in clinical trials.
Presenter
Jessica Emerson, MS, Ph.D.
Scientific Advisor at Clario
Dr. Emerson is a scientist with over 15 years of experience in behavioral and social science research focusing on the role of technology in measuring and intervening on health behaviors. She has extensive experience in eCOA database design and management. She is currently a Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. In her current role she supports sponsors and CROs in eCOA design best practices and preliminary study set-up to optimize the reliability of eCOA data.