Keywords: medical devices regulation, MDR, post-approval studies, PMCF, PCMF Investigation, clinical investigation, GDPR Researchers beware! The new European Union Medical Devices Regulation1 comes into force on the 26th May 2021 Continue Reading
CONTEXT: This is a serious amount of data that OM1 have managed to amass on Rheumatoid Arthritis patients, with over 200,000 adults and over 5000 juveniles being followed in registries. Continue Reading
CONTEXT: Report from the American Academy of Neurology on Biogen’s main two MS compounds, with RWE showing value on detecting patient QoL and overall treatment preferences. READ TIME: 2 mins Quality Level Continue Reading
CONTEXT: Commercial announcement of another pharmaceutical company securing access to RWD, in this case across oncology centres in France. IMPACT: Medium READ TIME: 1 min Quality Level Mean [1 – Continue Reading
CONTEXT: Publication of an RWR study in rheumatoid arthritis showing equivalent safety profile between a biologic DMARD and an oral Janus kinase inhibitor. IMPACT: Low READ TIME: 2 mins Continue Reading
CONTEXT: Publication of a peer reviewed study in the ASCO journal showing RWE derived mortality data and the improvements this will confer in future study design endpoints and trial patient Continue Reading
CONTEXT: Yet another announcement of a venture capital funded company focused on commercialising real-world data sources | Are we opening up sources or slamming the door shut unless you have Continue Reading
CONTEXT: A comprehensive summary of multiple studies | Low key press release with potentially big impact in the real world IMPACT: Medium READ TIME: 3 mins Quality Level Mean [1 Continue Reading
CONTEXT: When the world falls apart, we still (thankfully) have studies focusing on the stuff (viruses) that impact us when we aren’t focusing on COVID | This is a retrospective Continue Reading
CONTEXT: At first glance this interview article about an app developed to measure a set of performance indicators may seem to be on the fringes of “proper science”. However, patients Continue Reading
