Decentralized trials have expanded the possibilities of clinical research by bringing studies closer to patients, accelerating recruitment, and capturing data in real-world settings.
By 2030, the decentralized trial market is expected to reach $13.3 billion, but its continued success hinges on data integration. Without seamless connection across devices, sites, and sources, even the most promising studies risk breakdowns, delays, and lost insights.
Decentralized and hybrid clinical trials have the unlimited potential to deliver rich insights from large volumes of data, including vital signs from wearables, clinician assessments, and patient-reported outcomes, but only if pain points are addressed early and often.
Sponsors are responsible for collecting and analyzing troves of data, and they must also make sure data sources are connected, or they risk a breakdown. A recent international COPD study required the authors to create a unified data ecosystem to transfer data from multiple sources, allowing for meaningful comparison and analysis.
While decentralized and hybrid trials offer a chance to collect data on a larger scale than a fully in-person trial, several defining risks come along with using multiple sites and data sources.
One major challenge is data fragmentation. In the COPD study, physician-reported data and patient questionnaires were uploaded to the Electronic Data Capture system while biometric data was stored in the cloud, making it hard to see the full picture.
Planning for data gaps is essential to gathering quality data, especially in instances where uploads fail, are incomplete or patients skip entries. These lapses will throw off results unless they are caught quickly.
Decentralized and hybrid trials also rely on different devices and service providers, which can add layers of complexity. In the COPD study, the ecosystem was necessary because data from multiple sources needed to be formatted and transferred to enable meaningful comparison and analysis.
Another challenge that can cause data gaps is when participants struggle with technology or stop using it, leading to a drop in data quality. It’s imperative that sponsors can help participants troubleshoot problems before they become disengaged and data becomes unreliable.
Sponsors planning decentralized clinical trials must not only anticipate data vulnerabilities but design systems that prevent them. Fragmented or incomplete data can derail even the most promising studies, but with the right infrastructure, integration is an advantage rather than a liability.
Here are four ways sponsors can reduce risk, improve data integrity, and keep participants engaged:
Decentralized trials reduce participant burden and provide the opportunity for real-world data collection. Without proper systems in place to mine and integrate the data, the trial’s results could suffer. Learn how Vivalink’s remote data capture services can improve trial results.