Clinical Pharmacology – Biomolecular
2019 PharmSci 360
In recent years, the potential utility of real world data (RWD) and real world evidence (RWE) have been much discussed, as RWD can generate RWE that may not be obtained from typical randomized clinical trials. RWD can be especially useful for small populations who are underrepresented in clinical trials. Among sources of RWD, electronic health records (EHRs) are rich resource that can be used in a variety of studies to explore comparative effectiveness, pharmacoepidemiology, pharmacogenomics, and post-marketing pharmacokinetic and pharmacodynamics for various populations including special populations. For all these study types, acquisition of accurate medication data is critically important with a wide spectrum of granularity necessary in dosing information depending on study aim. Obtaining accurate data from EHRs is a fundamental step but involves many challenges. We will discuss the current status of using EHRs for medication-based studies, and key challenges that must be addressed along this path. We will propose how these challenges could be overcome and discuss how to achieve common goals, as efficient collaborations across institutions are necessary to study small populations with adequate power.