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How will Researchers Tackle the Growing Challenge of External Data in 2024?

In a recent survey of clinical trial professionals, the team at eClinical Solutions learned about how our industry peers and colleagues are feeling about data from external sources (e.g., coming from outside a traditional electronic data capture system – EDC). Respondents included professionals specializing in data management, clinical operations, statistical programming, biometrics, and other roles. The survey highlighted an interesting trend – active integrations of some specific external data source types are not accelerating as may have been expected. This insight sheds light on key dynamics shaping our industry, particularly in the realm of decentralized clinical trial (DCT) approaches.

Use of New External Data Sources – Preference for Direct Measurements?

According to this year’s survey respondents, uptake of new external data sources is more moderate than many in the industry anticipated. This can be partly linked to the sluggish adoption of DCT methods. DCTs are becoming more common, but at a more conservative pace than many thought following the rapid increase due to COVID-19 restrictions. While the survey shows continued interest from respondents to diversify data types, implementation concerning wearable devices and real-world data appears to lag.

Another contributing factor could be the sheer volume of widely varying external data types leaving many research teams not knowing which data sources will be most useful for their studies. The types of external data sources that are in use vary, but there is a clear preference for sources that provide more direct and specific measurements. This includes data from central and local labs, Interactive Response Technology (IRT), biomarkers, and imaging. It is understandable, as these sources supply data that is immediately useful, while other sources may deliver data for which the full value may not immediately be known. Over time, it is likely that the volumes of data collected from all external data sources will result in the discovery of new endpoints and will be used to identify safety and efficacy trends more quickly – among many other possibilities.

DCT Barriers

The industry’s measured adoption of hybrid and fully decentralized trial designs demonstrated in the survey results can be accounted for by several likely factors. These include the complexity of the vendor ecosystem (e.g., the need to work with a variety of vendors for things like ePRO, virtual visit technology, wearables, etc., along with the need for systems and workflows that integrate the data from all these vendor solutions), data security concerns, and the sometimes-unclear demands on trial sites. Moreover, the cautious and conservative nature of the industry means there are limited success stories that can make sponsors more comfortable implementing these strategies.

What Can We Take Away Regarding the Future of External Data Sources?

Despite limited growth in the use of some external data sources, the industry is gradually adapting as the ability to effectively utilize data from diverse sources is becoming increasingly important. Certainly, there are questions about how to effectively integrate all these data sources and how best to extract their value, but the effort to do so will help us to learn more about patients. Further, delivering those insights faster can help us unlock efficiencies resulting in new therapies delivered to patients more quickly.

According to the survey, researchers are increasingly interested in collaborating with partners that can help them navigate these challenges, seeking guidance on data acquisition, and investing in technologies capable of managing expanding data volumes. The team at eClinical Solutions has set up a Center of Excellence for External Data, aimed at helping researchers to adopt best practices and craft the kinds of robust data processing and standardization infrastructures necessary for handling complex modern studies. Currently, elluminate® is well-positioned to support the integration of multiple external data sources into study designs, with the eClinical Solutions team able to offer guidance on how to choose the most appropriate sources for a given study and how implement them seamlessly.

For more information from our 2024 Industry Outlook survey, view the full report.

Industry Outlook for 2024

2024 Industry Outlook
Driving Tomorrow’s Breakthroughs with Clinical Data Transformation

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2024 Industry Outlook: Driving Tomorrow’s Breakthroughs with Clinical Data Transformation