EMA Officials Call for Using EHRs to Better Understand Pharmaceuticals
Posted 01 October 2018 | By
Senior leaders from the European Medicines Agency (EMA) and several other European agencies are calling for the creation of a “learning healthcare system” based on electronic health records and other collected data to complement data collected from randomized controlled trials (RCTs).
Real world data (RWD) has been at the forefront of conversations on how to make research and development and precision medicine more useful, though as the leaders write, “Even the best positioned countries still face challenges that may limit their future success in harnessing the potential of RWD.”
Regulators, often in collaboration with academia and industry, already make use of RWD in pharmacovigilance, though RWD can also help supplement RCTs in some settings.
“An area where the need for additional data sources and methodologies has been apparent for some time is new, highly promising medicines that are being fast-tracked, and for which continued close monitoring and post-approval benefit-risk (re-) assessment is paramount.
“These (often highly-priced) products also need monitoring to judge if the expected outcome is realized in everyday clinical practice, and to decide if a high price is still justified,” the authors write
And in this new learning healthcare system, the way in which patient data are generated, stored and used in the EHR is at the heart of the system, though requirements regarding data standardization, quality, connectivity and usability of EHRs “will far exceed” those of the routine use of EHRs.
“Relying (almost exclusively) on RCTs will not allow for translating the current pace of progress in the life sciences into new and better treatments for patients,” they write.