Safe and effective healthcare matters for society as a whole.
Katja Neubauer
from the European Commission opened the session with an update on EU
initiatives with regard to digital health. She considered 3 priority areas on
digitizing health and care: access of the citizen to his or her data for
example in electronic medical records and electronic prescribing; access to big
data to improve health policy and regulatory decisions; and using digital
health make policy decisions more patient-centred.
She discussed
clinical use studies, including development of European Reference rare diseases,
applying digital health to anticipating epidemics and EU-wide infectious
threats and applying Real World Data in medicines development.
An EC report on Digital Single Market strategy is due to be published on 25th April.
An EC report on Digital Single Market strategy is due to be published on 25th April.
Hans-Georg
Eichler from the EMA went on to discuss the relevance of real world evidence to
regulation of medicines, including understanding efficacy and monitoring for
unexpected risk and for long-term risk. In particular, he considered use of real
world evidence to match the speed of science progress with timely integration
of innovations into clinical practice.
He considered case
studies on accelerating drug development, contrasting findings from real world
evidence with those from classical randomized clinical trials; applying real
world evidence to monitoring potential long term adverse effects of medicines –
for example from risks of insertional mutagenesis following gene therapy for
thalassaemia which needs surveillance for decades; and applying real world
evidence to understanding therapeutic complexity – for example deciphering
combinatorial complexity in oncology treatment with regard to differences in
therapeutic impact from treatment order, dose and washout duration between
treatments.
He also discussed applying learning for health care from other sectors (aviation, automotive …), including data-driven innovation from rapid feedback loops.
He also discussed applying learning for health care from other sectors (aviation, automotive …), including data-driven innovation from rapid feedback loops.
Alison Cave from
the EMA discussed key points from recent workshops hosted by the Agency. She
stressed the need for a common data model for Europe. A key theme arising from
discussion of EMA registries had been the need for common core data elements,
checks on data quality (consistency, accuracy and completeness), long-term
curation, availability and governance.
Jane Mosely discussed how real-world evidence and patient registries can be used to support early access to medicines, risk-benefit analysis and provide rapid replication within different populations of initial findings. She noted that there are currently limited requests for data from real-world evidence to support pre-authorisation decisions and post-authorisation questions about safety and efficacy. Some aspects which need to be considered include eligibility of participants, outcome definition, patient safety, and extrapolation of findings throughout the EU.
Jane Mosely discussed how real-world evidence and patient registries can be used to support early access to medicines, risk-benefit analysis and provide rapid replication within different populations of initial findings. She noted that there are currently limited requests for data from real-world evidence to support pre-authorisation decisions and post-authorisation questions about safety and efficacy. Some aspects which need to be considered include eligibility of participants, outcome definition, patient safety, and extrapolation of findings throughout the EU.
Alexios Skarlatos (EMA) and Dr. César Hernández García (Spanish Agency of Medicines and Medical Devices) discussed Electronic Product Information. Steps include consultation on revising Patient Leaflet content and adding agreed new content, including targeted messages for relevant subgroups of patients. There are already case studies from the Netherlands (Watchyourmeds), quick guides for patients in Norway and in Spain structured product information accessible e.g. by scanned quick response (QR) codes. International standards are needed and transition to a Digital first model. There will be a European Commission-EMA-HMA multistakeholder workshop on the use of electronic Summary of medical Product Characteristics (SmPC)/Patient Leaflets (PL) on 28th – 29th November 2018.
Further speakers will discuss from health professional, regulator, patient, consumer perspectives Real World Evidence (Kieran Breen, Patient Representative on the EMA Committee for Advanced Therapies), mHealth (Kathi Apostolidis, European Cancer Patient Coalition) and Social Media (Caroline Morton, International Bureau for Epilepsy).
More about the
meeting and the presentations can be found on the EMA
website.
