Clinical trials are the backbone of medical innovation. The insights they provide can unlock the door to vital breakthroughs and life-saving treatments that benefit patients across the globe.
Successful clinical trials depend on having access to high-quality data. But despite this, many research teams still rely on traditional paper-based data collection methods. For example, paper reported outcomes (PRO) and eDiaries. Not only are these methods inefficient, they're prone to transcription errors and compliance issues that can compromise study integrity.
The alternative is to use electronic data capture and management solutions, like electronic clinical outcome assessment (eCOA) systems. Working in tandem with other eClinical systems, they allow participants to share data directly with your research teams.
An electronic approach is quicker, easier, and reduces the risk of human error – leading to better study outcomes. Let's take a closer look.
What is eCOA in clinical trials?
eCOA systems are web-based or mobile applications that allow trial participants to share data directly with your research teams using electronic devices. These can be dedicated devices provisioned for the length of the study or the participant's personal laptop, smartphone, or tablet if you use a system with bring your own device (BYOD) capabilities.
Crucially, eCOA systems let you capture a range of participant outcomes, including:
- Patient-reported outcomes (PROs): firsthand accounts from study participants about symptoms, treatment effects, and quality of life.
- Clinician-reported outcomes (ClinROs): professional assessments conducted by healthcare providers during examinations.
- Observer-reported outcomes (ObsROs): insights from caregivers or family members who regularly interact with the participant.
- Performance outcomes (PerfOs): objective measurements from tasks performed by participants. For example, to evaluate physical or cognitive function.
Most eCOA systems automatically validate entries, reducing errors and improving data integrity. When integrated with Electronic Data Capture (EDC) software, you get a comprehensive data management solution that eliminates manual transcription and gives you a complete view of participant data.
What’s the difference between eCOA and ePRO?
People often refer to eCOA and ePRO (electronic patient-reported outcome) interchangeably. While there are some similarities, they serve distinct purposes.
- eCOA is an umbrella that encompasses various methods for collecting clinical outcome data from patients, clinicians, and observers.
- ePRO is more specific, focusing on collecting data directly from patients – typically regarding health status or treatment experiences. This makes ePRO a subset of eCOA.
Benefits of eCOA vs. paper-based systems
The quickest way to understand the benefits of eCOA in clinical trials is to compare it with traditional, paper-based methods. This reveals four main advantages:
- Real-time data capture and monitoring
- Improved data quality
- Better patient engagement
- Global accessibility
Real-time data capture and monitoring
eCOA systems enable immediate data collection and transmission, giving your research teams easy access to real-time participant insights at every stage of your trial. With uninterrupted visibility, you can:
- Identify potential issues quickly
- Make more accurate predictions based on emerging data
- Reduce time between data collection and analysis
- Receive instant notification of adverse events
Improved data quality
Paper-based collection is prone to errors that can compromise study results. eCOA systems address these issues through:
- Built-in validation checks that flag inconsistent entries
- Required fields that prevent incomplete submissions
- Standardized data formats that eliminate transcription errors
- Automatic date and time stamps for accurate compliance monitoring
Better patient engagement
eCOA systems create more accessible and user-friendly experiences, improving engagement and protocol adherence. Features like automated reminders for scheduled assessments, intuitive reporting interfaces, and streamlined data entry eliminate much of the hassle that discourages participants from engaging with clinical studies.
Global accessibility
One of the biggest drawbacks of using paper-based data collection to run clinical trials is that it effectively excludes people living in remote locations from participating. After all, you can't expect someone who lives hours away from your facility to make regular on-site visits.
eCOA systems break down these geographical barriers with:
- Cloud-based access enabling participation regardless of location
- Standardized assessments ensuring consistency across diverse populations
- Reduced need for on-site visits making trials more accessible
Advanced systems offer multi-language support, allowing you to collect data consistently across regions.
By enabling participants to share trial updates directly through their smart devices, it doesn't matter if they live 1 or 1,000 miles from your facility.
eCOA in clinical trials: 4 best practices to guide your implementation
Successful eCOA implementation requires careful planning and thoughtful execution. Follow these best practices to ensure you and your trial participants get the most out of your eCOA system.
1. Incorporate eCOA into trial design from the start
Rather than treating it as an add-on, incorporate your eCOA system into your trial design from the beginning. Identify the type of data you want to collect and how this will impact participants. This is particularly important when you're deciding how frequently to conduct assessments. For the most cohesive experience, design your data collection schedule to maximize compliance while ensuring eCOA requirements align with study objectives.
2. Evaluate available tools and providers
The eCOA market is diverse. There are many solutions to choose from, each offering different capabilities and specializations. Before investing in a solution, assess the technical capabilities and integration options to ensure it complies with relevant regulatory requirements. For example, 21 CFR Part 11 and GDPR.
Consider the provider's industry experience, implementation support, and product roadmap to ensure they can support your current and future needs. Your evaluation should include the system's scalability and flexibility to accommodate protocol amendments and evolving research requirements.
3. Focus on user experience
Trials that are easy to participate in always get more engagement than those that aren't. When researching eCOA systems, prioritize those that offer an intuitive user interface and minimize the number of steps required to complete assessments. Once you've settled on a solution, provide clear instructions and support to streamline the onboarding process for researchers and participants.
4. Implement data validation and set response parameters
Maintaining data integrity requires thoughtful validation processes throughout the assessment lifecycle. Set appropriate validation checks for each assessment type and establish clear protocols for reviewing flagged entries. This will provide a comprehensive audit trail of system interactions and data modifications.
Connecting researchers and patients with eCOA
Embracing eCOA in clinical trials benefits everyone. A digital approach to data collection enables you to conduct more efficient clinical studies anywhere on the globe. For trial participants, eCOA systems provide smoother, more convenient experiences - removing many of the barriers that prevent people from accessing potentially life-saving research.
Why Viedoc?
Viedoc combines reliable data collection, integrated televisit and eConsent support, and secure document sharing into a single, intuitive eCOA solution.
Our web-based interface works seamlessly on any phone, tablet, or computer, allowing subjects to share data effortlessly using their personal devices. So, you can keep subjects engaged while capturing the data you need to support your study.
- BYOD: A web-based interface allowing for device-independent access for all study subjects.
- A fully integrated ePRO solution: Utilizing the same data storage as Viedoc Clinic.
- Efficient user and site-centric workflows: Streamlined patient workflow, allowing a combination of site visits and home assessments conducted by the subject.
- Configurable reminders: Configurable reminders can be sent through email or SMS to participants.
- Intuitive UI: User interface designed with study subjects in mind.
- Multi-language support: Nearly 50 languages are available to include patients across the world.
