2015 and Beyond: What’s Next for Clinical Data Management and Investments

The emergence of EDC systems to collect trial data electronically at their source has significantly advanced clinical trial research over the past decade. While this shift towards web-based collection and management shows improvements in achieving cleaner data and more efficient processes, there is still a lot of room for improvement. The next great advancement in clinical trials will require revamping the currently onerous process. In the coming year, we expect to see sponsors focused on making better use of their data investments that are now electronically available through EDC and other systems.

Designed specifically to replace error prone and ineffective practices of paper and eCRF collection methods, EDC systems were merely digitizing an archaic process. Other than reducing paper-based systems, not much has changed. Sponsors haven’t received better visibility into their entire clinical portfolio, faster study startup, or better data availability. Additionally, with so many different types of commoditized EDC systems available, communication across the varying systems is greatly delayed.  Data collection during a trial is necessary but it is no longer sufficient.

Enter EHR

The industry continues to look to incorporate Electronic Health Records (EHRs) in the clinical trial realm to supplement the constraints of EDCs.

EHRs are now widely adopted by hospitals and clinical trials look to reuse the data for more real-world evidence. EHRs can help supplement clinical trials with a more complete picture of a patient, for example by providing a more thorough medical history. EHRs also have the potential to provide clinical researchers with the data of millions of patients to researchers, which can enable a more thorough or helpful understanding.

The large quantity EHR data can also be a valuable mechanism for protocol design and patient recruitment. Analysis can be launched against the volumes of EHR data to identify patients who meet study criteria. Detailed patient health records help to reduce errors by identifying safety concerns prior to patient enrollment.

Early Adopters See Big Rewards

The evident use case of EHRs for recruitment has already attracted pioneers such as the Mayo Clinic, Penn Medicine, and Giesinger Health, who have all seen increases in patient identification, enrollment and referrals. Additionally, the established ECR4CR program demonstrates effective use of international EHR data while protecting patient privacy. The program has successfully accessed clinical data from more than five million patients, expanding patient information on a global scale. As EHRs continue to deliver greater volumes of data, it is critical to incorporate processes for enhanced interpretation.
 

Looking Ahead

In the year ahead, we expect analytics platforms to play a key role in unlocking the potential of EHR data, particularly cloud-based systems that can bring all relevant data together in one place.

Cloud based tools facilitate real-time access to data, supporting Sponsors and CROs in running queries as often as necessary. Because there remains an array of EDC systems and the widespread adoption of EHR systems is still distant, utilizing these tools will leverage the increasing volume of available data to ensure better patient safety and bring new treatments to market sooner.

Rick Morrison, CEO, Comprehend.