How Israel is Revolutionizing Clinical Trial Innovation

Abstract

The clinical trials industry, critical to advancing medical research and patient care, is severely lagging in technological innovation. Since 2018, the FDA has been recommending the implementation of solutions that will connect sponsors with medical centers and reduce the need for manual data transfer. And yet, few sponsors or medical centers have taken steps to solve these problems or implement the FDA’s guidelines.

This case study explores the pressing need for global solutions to improve data management processes in clinical trials, with a focus on Israel's pioneering adoption of EHR-to-EDC streaming technology on a national level. By examining Israel's model, the study demonstrates how embracing technological innovation can improve data accuracy, reduce staff burden, and enhance patient access to clinical trials on a global scale.

The Problem

Unlike other industries that have embraced digital transformation, clinical trials still rely heavily on outdated, manual processes. A glaring example of this is the continued practice of manually transferring data from electronic health records (EHR) at medical centers to the electronic data capture (EDC) systems of clinical trial sponsors. This process is not only tedious and time-consuming, but also prone to errors, which compromise data quality and delay trial outcomes.  

The problem is exacerbated by the growing volume of data generated by clinical trials. A study by the Tufts Center for the Study of Drug Development reveals that the average phase III oncology trial now collects 3.6 million data points—a threefold increase from just a decade ago. Despite this surge in data, the number of clinical trial staff has not increased proportionally, leading to overworked staff with high turnover rates.

Manual data extraction is currently a costly and cumbersome barrier for sponsors trying to access patient data from medical centers. This leads to the majority of clinical trials being held in large, urban hospitals, excluding patients for whom travel is a logistical or financial burden, and causing enrolment challenges for sponsors. Recent reports reveal a 26% rise in the enrolment duration across all trial phases over the last five years.

The solution lies in a global approach to data management that connects medical centers worldwide directly to electronic data capture (EDC) systems. Such a solution would allow sponsors to efficiently extract EHR data from a far broader range of medical centers, while reducing site staff burden. This model would improve and expedite data collection and expand patient access to potentially life-saving treatments.

Background

The 21st Century Cures Act, passed in the United States in December 2016, was a significant step toward modernizing the management of healthcare data. Among its provisions was the requirement for application programming interface (API) access to all elements of a patient’s electronic health record (EHR) ‘without special effort.’ The intent was to make EHR data more accessible and usable, particularly in the context of clinical trials. However, several challenges have hindered the full realization of this vision:

Security concerns - The transfer of sensitive patient data raises significant security issues which have slowed the adoption of interoperable systems.

Privacy concerns - Ensuring patient confidentiality while enabling data sharing remains a complex challenge.

Lack of standardized coding - Inconsistent coding systems across different EHR platforms complicates data integration into a single format for EDCs.

Data messiness - The unstructured nature of much of the data within EHRs makes it difficult to automate its extraction and transfer in useable formats.

Complex data classification - Differing classification systems across institutions add another layer of difficulty.

Following the 21st Century Cures Act, the FDA, in its 2018 guidance, emphasized the importance of integrating EHRs with other data management systems to improve the efficiency and accuracy of clinical trial data management. Despite these recommendations and the clear need for such technological advances, the adoption of technologies like EHR-to-EDC streaming has been slow, leaving clinical trials mired in outdated manual processes.

Israel Steps Up

While the FDA was the first regulatory body to suggest widespread EHR-to-EDC integration, it is Israel that has taken the first concrete steps to implement this technology on a nationwide scale, by incentivizing hospitals to embrace the technology. As the first country to achieve widespread adoption, Israel sets an example for how a strategic top-down approach can transform clinical trials, benefiting both sponsors and patients alike.

With the global nature of clinical trials and the need to recruit patients from diverse populations, a global solution is essential to fully meet sponsors' data collection requirements. The rise of site-specific or sponsor-specific solutions, which have slowly emerged in the U.S. in response to FDA guidance, only partially addresses the issue. These site-specific solutions limit the expansion of trials to a broader network and restrict access for patients in rural or less-connected areas. Additionally, they require costly and complex integrations between each medical center and sponsor’s EDC, making scaling difficult and limiting the reach of trials.

Israel, in contrast, has taken a broader approach, with the Israel Innovation Authority (IIA) providing grants to medical centers to facilitate the adoption of EHR-to-EDC streaming solutions so that all major research centers will be able to stream EHR data. Medical centers across the country, including Sheba Tel-Hashomer Medical Center, Hadassah Medical Organization, Rambam, Assuta Medical Center, Rabin Medical Center, and many medical centers within the Clalit network, have already integrated with Yonalink’s EHR-to-EDC streaming solution with the intention of being able to easily stream clinical trial data to sponsors and to bring more trials to Israel.  

This nationwide network positions Israel as a model for other countries, demonstrating how a unified approach to data extraction can improve data quality and provide sponsors with a wider network of medical centers and patients. The ability to rapidly extract accurate data from nearly any patient's EHR allows sponsors to access higher quality data in near real-time and reduce source data verification (SDV) time, while patients benefit from greater access to clinical trials without the need to travel long distances.

In the pilot phase of the project, all twenty-one participating Israeli medical centers successfully transmitted accurate data to Yonalink’s EDC. Additionally, data from patients in an oncology trial was transferred and verified for accuracy. The results showed that 93% of the requested data was transmitted, with a perfect 100% accuracy rate—unmatched in the industry so far.

Conclusion

There is a growing recognition among clinical trial regulators worldwide of the need to embrace new technologies to improve data management, oversight, and staff well-being. EHR-to-EDC streaming provides one such solution by enabling effortless data transfer from any medical center to the sponsor’s EDC, significantly reducing the time and errors associated with manual processes.  

Western Europe’s share of clinical trials has declined by 25 percent in the past five years, while the share of clinical trials in Central and Eastern Europe has declined by 33 percent. In the UK, the number of clinical trials conducted in 2022 was approximately half the number conducted in 2012. It’s time to make it easier for sponsors to access clinical data from medical centers around the world, and to make it easier for medical centers to participate in trials by reducing the associated burden on hospital staff.  

Israel has demonstrated that an organized plan combined with government incentives can expedite the adoption process and can make trial access easier for both medical centers and patients. It’s only a matter of time before other countries follow suit.

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