By Brittany Wade 

August 2, 2022 | The term “real-world data” conjures imagery of vast repositories chock full of electronic health records from hospitals and other healthcare facilities. Less evident in this category are data captured by wearable health-monitoring devices and health-related data gathered from environmental sensors. Despite their increasing value across multiple applications, the rising tally of data sources presents clinical researchers with several significant challenges. 

These challenges, particularly in establishing data that are FAIR—findable, accessible, interoperable, and reusable—make it extremely difficult to extract research-specific datasets from massive unstructured and uncoded archives. 

On a mission to help scientists foster innovative healthcare and conduct more efficient research, The European Institute for Innovation through Health Data (i~HD) encourages cutting-edge solutions for creating, using, and sharing high-quality information. Recently, the institute facilitated the development and implementation of research data networks. 

“What we are seeing now is a more proactive anticipatory mission to connect multiple repositories of health data and to enable a strongly de-identified, but fully anonymized, dataset to be available for research questions,” Dipak Kalra, president of i~HD, tells Deborah Borfitz, Clinical Research News senior writer and host of the Scope of Things podcast.  

Scaling in Europe with some connections to North America and Asia, research data networks consist of multiple linked health data storehouses that provide highly specific results in response to data queries. Most notably, they provide distinct patient subgroups as potential qualifiers for prospective studies. Additionally, network output quickly and easily adjusts to revised study protocols. 

While real-world data will never supersede the exacting information gleaned from randomized controlled trials, it could inform the direction of a new trial or provide a more accurate estimate of patient numbers to assist with protocol feasibility. 

“The federated networks can become a valuable tool for protocol optimization, enabling faster and more accurate patient recruitment, and reducing the number of protocol amendments, which are expensive and time-consuming. This is a case of real-world data helping the randomized control trial landscape,” says Kalra. 

Of course, a growing number of researchers prefer real-world data. Kalra acknowledges that the information is “messier, untidy, and lower quality.” However, it generates faster, is more affordable, and offers access to data from millions of patients—a sample size randomized controlled trials could never reach. 

Industry-Wide Challenges 

A lack of data quality, interoperability issues, and industry resistance to methodology shifts make data and knowledge-sharing burdensome. Moreover, as the public shares its growing concerns about data privacy and safety, governmental and regulatory bodies pass new data-privacy regulations more stringent than the last. 

Some of the network’s data is pseudonymized—pseudonyms replace patient information with links to the original identifiers—to protect against accidental disclosure and align with the European Commission’s General Data Protection Regulation (GDPR) standards. GDPR was introduced four years ago as Europe’s ideal for data usage and the protection of patient rights. By its own admission, GDPR is “the toughest privacy and security law in the world.” The Health Insurance Portability and Accountability Act of 1996, also known as HIPAA, is the closest American equivalent. 

Kalra also points to incohesive business models and a reluctance to comply with industry standards as additional barriers. “The business models around data are very disjointed,” he says. “The people who want the best quality data aren’t actually the people who are spending the money to collect it.” 

Kalra thinks “joining incentivization dots”—a phrase he invented to illustrate stakeholders joining forces for the greater global good—is the solution to overcoming these barriers. The European Commission would most likely agree with this sentiment, given their release of the European Health Data Space proposal in May. Still in draft regulation, the proposal calls for a secure and standardized data-sharing ecosystem that enforces standard practices and gives patients more autonomy over their information. 

One of the biggest challenges to data creation and management is convincing the public of its value. Kalra and his colleagues make a concerted effort to educate patients on the human and organizational safeguards for data protection. Even with the possibility of an occasional breach, he finds that patients are more willing to share their data when they understand its tremendous impact on medical discoveries. 

Interestingly, Kalra reports that most patients are not solely motivated by personal benefits. Instead, the potential to help others–such as developing a cure that they themselves may never receive–is enough to incentivize participation. “We can do all we can technologically, in training, and good practices, but in the end, there is a piece to this success which lies with the goodwill of people,” reminds Kalra. 

A Silver Lining 

Given the current health and social climate, one would be remiss not to mention COVID-19 when discussing data sharing. The pandemic demonstrated the importance of accessing high-quality data quickly; however, it also highlighted the scientific community’s unpreparedness for such a task. 

“The pandemic is a situation from which we can learn and on which we must build because we would be negligent if we don’t,” Kalra warns. “The pandemic has shown how important it is to learn from big data in near to real-time in a way that absolutely transcends country boundaries. In the way the COVID-19 virus did not respect country boundaries, our evidence must not respect country boundaries either.” 

Though the pandemic has been quite disruptive and even tragic for many people, it taught the public to embrace data sharing in pursuit of medical triumphs. As a result, scientists can benefit from this newfound enthusiasm and continue the pioneering work of using data to improve global healthcare. 

The research community has an arduous road ahead as they continue to navigate the effects of COVID and wade through a seemingly never-ending sea of complex data. But, if there is a silver lining to recent events, Borfitz says it best: Everything that now seems like a chore will just be part of the cadence of how we handle health data and deploy it to develop new medicines. Kalra emphatically agrees.