The use of eCOA in clinical research has become increasingly popular. For example, the National Institutes for Health (NIH) has mandated that all clinical trials include an eCOA component by 2021.
An eCOA solution allows patients to access their health data from any location and provides a platform for patients to share their health information with their healthcare providers. The benefits of eCOA in clinical trials include:
A Patient-Centric Approach
eCOA is a patient-centric approach, which means that patients are at the center of the entire research process. eCOA gathers data from patients, field sites and other stakeholders involved in clinical research.
In essence, it’s a way to collect information from patients and other stakeholders involved in clinical trials. This can be done through surveys or interviews conducted by phone or in person by members of your team.
Advantages of eCOA in Clinical Trials
There are many advantages of eCOA in clinical trials, including:
- Reduced trial costs.
- Improved efficiency and quality (e.g., reduced cost per patient).
- Increased patient engagement (eCOA improves the local relevance for patients). According to Medable professionals, “Increase data quality with real-time insights.”
- Reduced burden on patients and clinicians (eCOA reduces the burden of participating in a clinical trial).
- Reductions of administrative costs for sponsors.
FDA Guidelines and eCOA
The FDA guidelines for ClinicalResearch.gov are still in their infancy. As of now, the use of eCOA is not required, and it is at the discretion of each investigator to decide whether or not they want to utilize this technology. The FDA does have a pilot program where they are working with companies like STATA, which provides various software packages that can be used for electronic case report forms (eCOAs).
Challenges of eCOA in Clinical Trials
- Easy to use and understand: The clinical research team needs to be able to quickly and easily access data, view results and make decisions. If the tool is complicated or time-consuming, this will affect their productivity.
- Scalable: With a large volume of documents coming through your system on a daily basis, it’s important that you can handle all of them without slowing down your process or losing data.
- Secure: Sensitive information must be protected from unauthorized access by both users inside and outside of your organization.
Adopting an eCOA Solution
eCOA can help improve patient recruitment and retention and reduce the costs of clinical trials. It also increases the quality of data collected. For example, suppose a client is conducting an asthma study and wants to recruit patients from non-English-speaking countries.
In that case, it will be more difficult for them to do so through traditional means like print advertisements or cold calling. With eCOA, however, they could advertise their study online with links directly to their website where people can sign up for the study in their native language. This way, clients can expand their reach without worrying about translation fees or language barriers.
The FDA guidelines for electronic clinical trial applications (eCTAs) offer a vision of the future of eCOA, in which clinical trials are conducted more efficiently and effectively. While there are many challenges to overcome before this vision comes to pass, it is clear that eCOA has a bright future ahead.
