eCOA Clinical Trials: A Simple, Cost-Effective Approach to Study Build
Advanced technology is supposed to help sponsors run clinical trials faster. So why are timelines getting longer?
A report from the Tufts Center for the Study of Drug Development (CSDD) found that the clinical phase of new drugs and biologics approved by the FDA between 2008 and 2013 took 83.1 months on average. Between 2014 and 2018, the clinical phase extended to an average of 89.8 months.
According to CSDD director Kenneth Getz, fragmented operating activity is one of the primary factors that contribute to growing timelines. What’s one way to limit fragmentation? Bring more clinical trial functions in-house. By making the most of internal resources, sponsors not only simplify operations, they reduce risk and operational costs.
Reduced vendor reliance doesn’t mean clinical trial sponsors must take on all the services their technology vendors provide. It means vendors must customize their services and solutions to suit their customers’ trials. They must also design solutions that accommodate all types of patient data and all types of platforms.
A DIY Approach to Study Build
Due to individual in-house capabilities, not every clinical trial requires a full suite of solutions — direct data capture (DDC), eCOA, ePRO, and eConsent — to capture data during patient visits. And not every clinical trial sponsor or CRO needs full-service support from their data capture vendor. As an alternative to a comprehensive technology partnership, these organizations can work with vendors using a personalized subscription-based model to bring more functions in- house. By doing so, they not only simplify operations, they also decrease costs, reduce risk, and improve efficiency.
Organizations with existing internal IT resources can take advantage of a subscription-based model to build studies themselves. The sponsor or CRO can license only the services they need, whether electronic patient-reported outcomes (ePRO), clinical outcome assessments (eCOA, ClinRO), informed consent (eConsent), bring your own device (BYOD) strategies, or translation support. The sponsor or CRO’s internal team would then design and build the study using a combination of their own capabilities and licensed technology.
By maximizing internal capabilities, sponsors and CROs can benefit in the following ways:
- Flexibility and control. Allow internal SMEs to weigh in on study build, giving them more control over the process. Real-time data access (using an eSource platform) gives sponsors more control of their data.
- Efficiency and speed. A build-it-yourself approach decreases study startup time. Organizations gain more control over their own study build, which allows them to move through the process faster.
- Cost savings. By subscribing to only the services and technology needed, organizations save on the cost typically required to purchase or license a full data capture platform technology suite. By using internal resources for the study build and deployment, they save even more.
- Drive additional revenue. CROs can create new revenue streams by initiating ePRO, eCOA, DDC, and/or a bring your own device (BYOD) strategy. They can bid on and win proposals previously lost to larger entities or companies that have acquired technology companies.
- Data visibility and interoperability. Study teams can access and review clinical data immediately. When sponsors can access data directly, they can run their own reports and drive their own insights.
Patient Data in Totality
To play a role in reducing operational complexity, data capture platforms must have a simple, intuitive interface that less tech-savvy individuals can use. They must also have the ability to integrate all the disparate technologies and devices that comprise today’s clinical trials.
Most data capture platforms aren’t equipped to effectively manage all the third-party technologies and devices used in DCTs. They aren’t holistic; they are merely aggregations of point solutions that evolved over time. They can’t seamlessly integrate and validate structured and unstructured data — from vitals to video — in an organized fashion. They can’t integrate the myriad telehealth platforms, remote patient monitoring tools, wearables, and other technologies involved in DCTs. To accomplish this requires a different platform architecture and data model.
To make DCTs seamless, data capture platforms must focus on patient data in totality. They must eliminate the distinctions between electronic data capture (EDC), electronic outcome assessments (ePRO, eCOA, ClinRO), and the EMR. They must also capture data depending on how patients choose to participate.
The data capture platform designed for DCTs must have inherent flexibility to allow sponsors to design trials in a manner that best suits the research, the patients, and the sites. To reduce the cost and complexity associated with new technology, vendors can empower sponsors and CROs to design and build studies themselves.
Services and Support Available by Subscription
Tiered subscription-based models exist in many other industries. In many cases, they allow small businesses to use powerful software for a fraction of the Fortune 500-level price. A subscription-based data capture service model allows sponsors and CROs to access eCOA, questionnaire libraries, and many other services, plus support, at precisely the level they need. This model, combined with integration, removes operational complexity while bringing efficiency and revenue gains.