I’m not exactly sure when in this digital era the modifiers “real-world” first became associated with the burgeoning resources of health-related data and analytics, but real-world data (RWD), and its derivative, real-world evidence (RWE), are growing in usage and acceptance. Within this overall trend is welcome progression from the initial focus on defining real-world data and testing analytic methods to now also actively refining the use of these new resources and tools to impact policy and practice.
An example of the growing importance of RWE is the non-binding guidance document from the Food and Drug Administration (FDA), “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” issued this past summer.
In commenting at the National Academy of Sciences on this effort, FDA Commissioner Scott Gottlieb, MD, noted:
"These approaches allow for more rapid data collection. It increases the likelihood that the evidence will be generated, because it’s already being gathered as a part of routine clinical practice. We’re now working on policies to support the use of RWE in the approval of new indications for already marketed drugs. This may be especially relevant in settings like rare diseases or other unmet medical needs, where it can be hard to enroll patients in clinical trials. We’re also expanding policies to enable the use of RWE to support post-approval drug study requirements.
But we must also be realistic about current limitations. Even if we made progress on the challenges, RWE won’t replace data from traditional clinical trial data in many cases. But we can achieve more opportunity in the pre- and post-market context to use RWE in settings where doing so will improve medical product development."
At AcademyHealth, we have had a front row seat to health services researchers and their collaborators leading this evolution into ‘real-world action.’ Perhaps the most obvious example are the 200 papers published in eGEMs, our peer-reviewed, open access journal created in 2013 to accelerate research and quality improvement using electronic health data. Each of these papers features cutting-edge and highly practical work from leaders in the field illuminating real world solutions to real-world problems.
We are pleased to complement and extend the work already shared through a new Call for Papers (CFP) this fall. We seek manuscripts addressing the following areas of real-world actions:
- Addressing clinical data quality challenges
- Consumer-facing technologies and digital health
- Data privacy and cybersecurity
- Population health analytics and real-world evidence
- Integrating data sources and systems
All submissions falling under this call will undergo eGEMs' rigorous editorial and double-blind peer review process before publication, and—once published—will be shared with and promoted to an audience that includes government officials, payers, industry, delivery systems, patients and consumers, policymakers, and researchers.
This call for papers closes on October 30, 2017. Manuscripts published as a part of this call for papers will be eligible for special promotion at Health Datapalooza 2018, a one-of-a-kind conference bringing together a diverse audience of more than 1,200 people all working to harness data and technology to improve health.
I’m looking forward to this next wave of innovative and informative work and hope you will join us at eGEMs to share your insights and examine the latest in this real and dynamic field.