European Officials Promote Use of EHRs to Gather Real-World Data on Pharmaceuticals

Real-world data are increasingly viewed as a crucial factor in the eventual acceptance of biosimilar drugs, and indeed, current real-world evidence points to the safety and efficacy of these products in the marketplace. In a recent paper, officials from the European Medicines Agency, the Organisation for Economic Cooperation, and other European government entities explained that such data can help make decisions about pharmaceuticals—from development to reimbursement—more efficient. To that end, the authors called for international cooperation on a learning healthcare system that will better harness these data.

The authors note that the expense of prospective data generation in a research setting is high, limiting the number of research questions that can be answered in a randomized controlled trial (RCT). Furthermore, RCTs are rarely large enough to detect infrequent outcomes, nor are they long enough to determine long-term outcomes.

Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients. However, current inadequacies of EHRs present a “technical bottleneck” to the objective of gathering real-world data.

The paper’s authors propose that governments establish and implement national health data governance frameworks to encourage the use of personal health data to serve the public interest. They also call for public engagement about the use of EHRs, policies that will support high-quality EHR data, incorporation of EHRs in national health statistics, linkage of EHRs with other key data for research, and cooperation among pharmaceutical developers and healthcare systems. Finally, the authors say, the collection of data must translate into the production of useful evidence.

“Perpetuating the 20th century model of the dedicated research setting and relying (almost exclusively) on RCTs will not allow for translating the current pace of progress in the life sciences into new and better treatment for patients,” say the authors. A coordinated and international effort will be key to speed the implementation of a true learning healthcare system for global benefit.

Reference

Eichler HG, Bloechl-Daum B, Broick K, et al. Data rich, information poor; can we use electronic health records to create a learning healthcare system for pharmaceuticals? [published online September 4, 2018] Clin Pharmacol Ther. https://onlinelibrary.wiley.com/resolve/doi?DOI=10.1002/cpt.1226. Accessed October 4, 2018.