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INTAGE Healthcare provides comprehensive solutions for a wide range of needs including pharmaceutical market research, clinical development, post-market studies, pharmaceutical rep activity support, switch-OTC market assessment and sales tracking. INTAGE Healthcare aims to continuously provide healthier and more beneficial “choices” to all healthcare consumers and create a society where people have lots of options and can make their own personal choices, an abundant society with vast potential. The company was founded in 1960 and is headquartered in Tokyo, Japan.
Phase III clinical study of QFR (Quantitative coronary flow ratio)
In recent years, the use of electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA) has become increasingly popular in clinical studies. These tools allow patients to report their symptoms and experiences in real-time, providing researchers with accurate and timely data. In this article, we will explore a study that used ePRO and eCOA, and the role that „Marvin“, our EDC system, played in the study.
5 Sites | >200 patients | Duration of study: >10 months
This study focused on the use of ePRO and eCOA in a clinical trial. The researchers were interested in understanding how these tools could improve the accuracy and reliability of patient-reported data, and whether they could streamline the data collection process. The study was conducted over a period of several months, during which patients were asked to report their symptoms and experiences using an ePRO system.
One of the key benefits of using ePRO and eCOA is that they can help to eliminate many of the common problems associated with traditional paper-based data collection methods. For example, patients may forget to fill out their forms, or they may be reluctant to report certain symptoms or experiences. With ePRO and eCOA, patients can report their symptoms in real-time, which can improve the accuracy and reliability of the data.
ePro and eCOA with Marvin
Marvin, was used to manage the study. While there was no special study setup required for this study, Marvin was able to improve the efficiency and simplied the study processes.
It was able to automate certain tasks, such as scheduling patient appointments and sending reminders to patients to complete their ePRO forms. In addition, the system was able to reuse existing configurations from other studies, which helped to reduce the time and effort required to set up the study. Marvin also provided a range of features and modules that were useful for the study. For example, the Patients/Centers/User/Reports feature was particularly valuable, as it allowed the researchers to easily manage patient data, track study progress, and generate reports. Additionally, Marvin was able to improve the quality of the data collected, as it provided real-time monitoring and validation of the data.
Despite the many benefits of using Marvin and ePRO/eCOA, there were some friction points encountered during the study. However, these were relatively minor, and did not significantly impact the overall success of the study. Overall, the study was a success, and the researchers were able to demonstrate the value of ePRO and eCOA in clinical trials.
Looking forward, the researchers would like to see improvements in the reporting and data download features of Marvin, particularly in conjunction with ePRO. They also noted that Marvin was able to cover multiple user groups in the study, including PIs and monitors.
„We have been using Marvin for about 3 years since 2020 in more than 10 trials at Intage, We appreciate Marvin's stability and security. The exceptional value for the cost and the sleek, modern interface proved to be game-changers for both our organization and clinical sites alike.“
In conclusion, the use of ePRO and eCOA in clinical trials can provide many benefits, including improved data accuracy and efficiency. When used in conjunction with an EDC system like Marvin, the benefits are even greater. While there are some friction points, the benefits of using these tools outweigh the challenges, and they are likely to become even more widely used in the future.
We extend our heartfelt gratitude to INTAGE, our esteemed partner for many years, and particularly to Mr. Akira Mizuo, Director of Clinical Development, for their invaluable insight and contributions.
XClinical, part of EvidentIQ offers an eClinical solution called Marvin, which is an End-to-End platform for managing electronic data capture (EDC) and clinical data management (CDM) in clinical trials. Marvin is designed to support the entire clinical trial process, from study setup and to data collection and analysis. The software offers a range of features and is also compliant with various regulatory requirements, including FDA 21 CFR Part 11, GCP, and CDISC standards. The software is used by various organizations worldwide, including pharmaceutical companies, contract research organizations (CROs), and academic research institutions, to improve the efficiency and quality of clinical trial data management.
Contact us to learn more about Marvin.
Image credit: istock-metamorworks
