Decentralized clinical trials are becoming more popular as organizations realize they can be done more efficiently and at lower costs than in the past. However, this also comes with some new challenges to consider, especially when data collection and reporting.
For decentralized clinical trials, eCOA (electronic case report) and ePRO (electronic protocol) are two technologies that can help improve the accuracy of your data collection process without requiring additional costs or staff members. Let’s take a look at these technologies in more detail.
Evidence of Action (eCOA) is a framework for data collection, analysis, and reporting. It is designed for randomized controlled trials that have moved from centralized locations into decentralized locations. Its primary goal is to support monitoring, auditing, and reporting at multiple levels of measurement. In particular, you can use it to help evaluate how well strategies are working by monitoring the real-world use of health technology.
When it comes to clinical trials, it’s hard to deny the importance of data collection and management. So many stakeholders are involved in the process, from the sponsors to regulatory agencies to the patients themselves. Each stakeholder depends on accurate data to make critical decisions about how the trial should proceed.
According to Medable, “The term Electronic Patient-Reported Outcome (ePRO) is a substitute for Internet-based questionnaires that record health-related information from patients.” Specialists can use an ePRO system for any disease or condition of interest. That includes psychiatric disorders such as mood, anxiety, psychotic or substance use disorders; chronic diseases such as cardiovascular diseases, diabetes mellitus, and inflammatory bowel disease; psychological treatment efficacy studies using pharmacological treatments or psychotherapies.
Both eCOA and ePRO are forms of electronic data capture (EDC). When it comes to eCOA vs ePRO, the main difference between them is that eCOA captures data at each site while ePRO collects it from a central location. If you’re considering using EDC for your clinical trial, you should weigh these two options carefully before deciding which one is right for you. Also, eCOA uses a mobile device while ePRO uses an online platform. If you’re using a tablet or smartphone for your study, you can use an app such as Smartsignals’ EDC to collect data on-site.
Many data collection strategies rely on participants to collect or submit data through self-reporting or maybe through some tools. However, some participants may lack computer or internet access or may lack the motivation to take part. Alternatively, professionals can use electronic Case Report Forms (eCRFs) to collect data from participants during clinical trials. Some advantages of using eCRFs include decreased data entry time for all stakeholders involved in clinical trials, improved data quality due to more accurate capture of information, and increased information security as it is stored electronically.
While there are many ways that physicians can collect data in a clinical trial, two of the most popular methods include eCOA and ePRO. Using these two methods together or separately makes it possible to collect more accurate data than ever before in decentralized clinical trials without increasing the cost or burden on research participants or providers.
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