Paper Recorded Outcome diaries have been used in clinical research for over 30 years. With the introduction of electronic patient recorded outcomes (ePRO), studies have been conducted to assess the benefits. ARITHMOS discusses the benefits of ePRO and EDC and good practice designs which will benefit biostatisticians and clinical data managers.
The benefits to an ePRO and EDC integration approach are:
- Less administrative and cost-effective
- Quicker data cleaning process, reducing data management costs
- Increase of patient compliance from 30% with paper to 90% with an electronic method such as devices
- Real-time data so trial leaders can make more educated and adaptive decisions and intervene immediately if a problem occurs
- Multi-language and global study data are in a single database
- Market shifting towards user-friendly devices
- Devices with “apps” allow access to study resources in a worldwide database
The integration of Patient Recorded Outcomes and Case Report Forms into Electronic Data Capture systems reduces the risk of trial delays by eliminating discrepancies which saves time and inevitably expenses and synchronizes data to offset conflicts in two isolated data sets.
Good Practice Designs
Integration should support data transfers in real time to eliminate the chance of outdated data sets and discrepancies. An integrated solution requires a central database to store data for all trial subjects, and security measures are in place to ensure confidentiality of data.
Integration requires an ePRO device with questionnaire, a connection (wireless, bluetooth, cable), HTTPS on the Internet, web server and a remote data capture EDC system. In terms of ePRO devices, the market is shifting towards individual, handheld devices which patients can use at home,. Smartphones and tablets are an ideal choice since they can be individually distributed with no assembly required, the questionnaire appears in the same format for every patient, data is submitted automatically and “apps” are available for download. 79% of physicians prefer the iPad for clinical use since new technology allows for diagnosis and tracking medical progress such as monitoring heartbeats and managing glucose levels.
To give a specific example, ARITHMOS recently participated in an observational study validating questionnaires for over 300 patients on an iPad 2 tablet. ARITHMOS’ responsibility was to integrate the questionnaire data from the iPad with an open source EDC system allowing the data to be transferred into a clinical database. Questionnaires were made available in the Apple Store and patient data on the iPad was encrypted. Personal credentials were needed to access the questionnaire. The iPad was an ideal choice for patients due to its large screen and buttons, multiple language support, touchscreen and automatic score computation.
ARITHMOS constructed a web portal to receive, decrypt and forward the data to the clinical database along with a prompt alerting system for any unsuccessful uploads. The study database was set up and validated in the eCRF application according to the study protocol. Real time metrics were made available to the Sponsor for questionnaire data comparison during the study.
Additionally, training was available for Investigators and a three tier HelpDesk system was available for Investigators and site personnel including iPad support and maintenance.
Benefits to Statisticians and Data Managers
- Study metrics are available up-to-date on eCRF
- Automated and real time patient binding
- Timelines: Blind Review Meeting and Database Lock possible only a few days after LPLV
- Statistical Reporting is carried out in the short term; very low risk of blinding errors
- Accelerated Query Management
- Real time data transfer in eCRF during the study
- Data Review in real time in eCRF
- Real time checks for inconsistencies
Overall, clinical trial professionals should be considering the ideal ePRO and EDC integration approach for their next clinical study including a careful evaluation of ePRO devices available and EDC systems which best fit study requirements. ePRO devices should improve patient compliance and meet the study objectives. Besides smartphones and tablets, specific devices like spirometry devices for respiratory studies, can also be integrated with EDC systems. In terms of EDC, every study has its requirements including budget restrictions and study build and setup. Contact ARITHMOS for a full evaluation of study needs and support in making the best clinical trial technology decisions.