The growth of EDC is driving the adoption of ePRO (Electronic Patient Recorded Outcomes) as clinical site staff are recognizing the benefits of using an integrated ePRO/EDC solution. Arithmos discusses how to integrate intuitive ePRO devices with an EDC system.
According to a survey conducted by Arithmos last year, clinical trial leaders cited immediate feedback, more accessible information and higher quality data as the main reasons for using EDC over paper. In recent years, there has been an increasing trend towards the use of electronic data capture due to its many benefits, such as:
- Less administrative and cost-effective
- Quicker data cleaning process, reducing Data Management costs
- Increase of patient compliance
- Full integration with ePRO devices
- Real-time data so trial leaders can make more educated and adaptive decisions
- Multi-language and global study data in a single database
- Market shifting towards user-friendly ePRO devices
- Devices with “apps” allow access to resources and medical information
Integration: ePRO and EDC
The integration of clinical systems puts all patient data into one system for easily accessible study results. Integrating Patient Recorded Outcomes and Case Report Forms into an EDC system produces the following benefits:
- Reduces the risk of trial delays by eliminating discrepancies which saves time and, inevitably, cuts expenses
- Synchronization of data to offset conflicts in two isolated datasets
Clinical trial leaders – including Monitors and Investigators – are concerned that the time required for integration will cause trial delays. However, there are Good Practice Designs and basic standards for eClinical integrations to reduce time and costs.
Integration should support data transfers in real time to eliminate the chance of outdated datasets and discrepancies, and integrated systems require a central database to store data for all trial subjects.
ePRO devices and EDC system integration requires minimal work and material. To connect the ePRO device to the EDC system, there needs to be an Internet connection such as wireless, bluetooth or plug-in as well as HTTPS on the Internet and a web server.
CDISC and the Operational Data Model (ODM) calls for XML-based formats that can accommodate all data values. Integration using industry standards is the best bet for real time views of global study progress.
Arithmos has extensive experience on the integration and validation of ePRO solutions for Oracle Clinical RDC as well as the assessment of data and patient diaries. We also have strategic partnerships with mobile and tablet experts for intuitive devices such as the iPad and Blackberry.
Arithmos has completed several EDC studies in therapeutic areas such as Respiratory, Neurology, Gynaecology, Cardiovascular, Oncology, Renal and Circulatory. In a Phase III Respiratory study with over 2000 patients in 175 sites, Arithmos integrated a spirometric device with RDC where 2 daily spirometric tests were performed and QoL diary data was collected. More recently, in a post-market dermatology study with 300 patients in 21 sites, Arithmos integrated a questionnaire on the iPad 2 to collect patient data.