What experience have we gained so far in conducting studies with real-world data to support EMA's regulatory decision making? 📊📉⚕️
Check out our new report to find out ⬇️ https://www.ema.europa.eu/en/news/use-real-world-evidence-regulatory-decision-making-ema-publishes-review-its-studies
#RealWorldData #BigData https://t.co/KBdAmqQwGh
🐦🔗: https://n.respublicae.eu/EMA_News/status/1672243938336428032
It's #DIAEurope2023 Day 3 and we are there!
➡️ Catch IHI Scientific Project Manager Nathalie Seigneuret in a panel on #regulatory issues.
➡️ @IMI_EHDEN@twitter.com is part of a session on #RealWorldData in safety signal assessments
Details: http://bit.ly/41xcinq
#diaeurope2023 #Regulatory #realworlddata
Für bestimmte Aufgaben können Beobachtungsdaten (wenn sie gut strukturiert erhoben werden) einen wertvollen Beitrag leisten. 👍
Die Autorin und die Autoren sprechen #Beobachtungsstudien ihren Wert ja nicht ab. Aber für #Nutzenbewertungen sind Nicht-RCTs hoch problematisch wegen der potenziellen Verzerrungen.
Der Weg, den sie empfehlen: "Effiziente RCTs *mit* #RealWorldData für Nutzenbewertungen".
https://www.iqwig.de/presse/pressemitteilungen/pressemitteilungen-detailseite_89728.html
#beobachtungsstudien #nutzenbewertungen #realworlddata
Unsere #Pressemitteilung zum #BMJ-Paper von Wieseler et al.
"Effiziente RCTs mit #RealWorldData für Nutzenbewertungen: evidenzbasierte Versorgung beschleunigen!"
Gemeinsam mit Kollegen der belgischen HTA-Agentur KCE werben drei Mitarbeiterinnen und Mitarbeiter des IQWiG im BMJ für effizient geplante und durchgeführte #RCTs auch auf vermeintlich schwierigem Terrain.
https://www.iqwig.de/presse/pressemitteilungen/pressemitteilungen-detailseite_89728.html
#pressemitteilung #bmj #realworlddata #rcts
3/
Investigating new drugs in routine practice after marketing authorisation (i.e. using #RealWorldData has been an integral part of accelerated approval concepts.
Recently, the debate was fuelled by availability of large data sets from electronic sources, e.g. electronic health records, claims data or patient registries.
In addition, there is the narrative of #RCTs becoming more and more difficult due to small patient populations or high costs.
https://www.q-centrix.com/service-lines/real-world-data/
Interested in #healthanalytics #realworlddata? #ClinicalResearch? Join us for this #webinar on taking control of your facilities clinical data for research! Please retoot for greater exposure!
#webinar #clinicalresearch #realworlddata #healthanalytics
https://www.q-centrix.com/service-lines/real-world-data/
Interested in #healthanalytics #realworlddata? #ClinicalResearch? Join us for this #webinar on taking control of your facilities clinical data for research! Please retoot for greater exposure!
#webinar #clinicalresearch #realworlddata #healthanalytics
https://www.q-centrix.com/service-lines/real-world-data/
Interested in #healthanalytics #realworlddata? #ClinicalResearch? Join us for this #webinar on taking control of your facilities clinical data for research!
#webinar #clinicalresearch #realworlddata #healthanalytics
#RealWorldData on the #Mpox vaccine show that it is effective, especially after 2⃣ doses.
Discussions are ongoing with developers of other vaccines for Mpox and other viruses of the same type.
🐦🔗: https://n.respublicae.eu/EMA_News/status/1625845803758518273
#realworlddata #mpox #EMAPresser
RT @ESCAdvocacy: Cardiovascular registries provide #RealWorldData with the potential to improve standards of care, monitor the safety of new devices and medications, and provide a collaborative infrastructure for observational research and #RCTs. 👉 #EuroHeart Project https://t.co/Y5y1f2PD9B
🐦🔗: https://nitter.eu/mgracacarvalho/status/1575821208326754305
#realworlddata #RCTs #EuroHeart
RT @EMA_News: Global regulators work towards strengthening collaboration on observational research beyond the #COVID19 pandemic.
Read more about the main findings of the latest #ICMRA regulatory workshop on COVID-19 observational studies and #realworlddata.
#COVID19 #ICMRA #realworlddata
Global regulators work towards strengthening collaboration on observational research beyond the #COVID19 pandemic.
Read more about the main findings of the latest #ICMRA regulatory workshop on COVID-19 observational studies and #realworlddata.
#COVID19 #ICMRA #realworlddata