Meeting Evidentiary Needs With Electronic Health Records

In the idealized healthcare environment of the future—perhaps another decade hence—both our care delivery system and our clinical research system will be built on a common information technology platform.

Providers and researchers alike will have access to a full, 360° view of all anonymized patients via an integrated network of Electronic Health Record (EHR) systems that “talk to one another.” The daily practice of medicine will furnish an endless stream of evidence that can be used to improve care in a continuous cycle of innovation. Thus, the real world will provide answers on which therapies are most effective, which treatment protocol is optimal, and perhaps even on the safety and efficacy of investigational therapies.

Already, despite the fact that EHR systems are not yet universally interoperable, they are a rich source of Real World Data (RWD) available to researchers. The number of systems being used in hospitals and physician practices has reached a critical mass.

In the EU, where as early as 2008 the European Commission set a goal of cross-border interoperability of electronic health records, the use of EHRs is expanding rapidly. It has, therefore, become easier and cost-effective to use EHRs to generate Real World Evidence (RWE) for regulators, payers, and other stakeholders.

Here, we discuss the growing use of RWD from EHR systems in observational studies and Pragmatic Clinical Trials, explaining what sponsors need to know in order to take advantage of these efficient approaches.