We have the technology and scientific knowledge to collect more data in clinical trials than ever before, giving the potential for greater insights. But do we have too much of a good thing?
A January report from the Tufts Center for the Study of Drug Development (CSDD) found that the number of endpoints for Phase II and III protocols grew by 27% between 2009 and 2020. Studies also collect three times more data today than in 2009 and require almost twice as many distinct procedures.
While using fewer clinical endpoints may help simplify clinical workflow, operationally, clinical trials have the potential to become more complex as sponsors adopt decentralized clinical trial (DCT) models. With the integration of telehealth, remote patient monitoring, home health, wearables, and apps, along with clinical trial management systems (CTMSs) and data capture (EDC, eSource) platforms, the industry needs a way to ensure DCTs run smoothly and efficiently while maintaining budgets and timelines.
One solution lies in reducing reliance on third-party vendors. Not every clinical trial needs 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 subscription-based model to bring more functions in-house. By doing so, they not only simplify operations, but also decrease costs, reduce risk, and improve efficiency.
A DIY Approach to Study Build
Organizations with internal IT resources can take advantage of a subscription-based model to build studies themselves. The sponsor or CRO would subscribe to 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 the data capture vendor's technology.
By lessening reliance on the vendor, sponsors and CROs can benefit in the following ways:
- Flexibility and control. Allowing internal SMEs to weigh in on study build gives 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 don't have to rely on a vendor to complete certain steps, 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 license a full data capture platform. 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 acquired technology companies.
- Data visibility and interoperability. Study teams can access and review clinical data immediately. By accessing data directly, they can run their own reports and drive their own insights.
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. Data capture platforms can do the same by offering a la carte eCOA, questionnaire libraries, and many other services plus support, at the level their customers need. This model reduces operational complexity while bringing efficiency and revenue gains.