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.
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.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.