CONTEXT: Commercial announcement of a tie up between TriNetX and Takeda to develop the latter’s use of RWD in their overall trail design strategy. IMPACT: Low READ TIME: 1 min Continue Reading
CONTEXT: Commercial merger announcement. Advise caution with regards to applicability in RWR as the technology platform is heavily clinical research focused. IMPACT: Low READ TIME: 1 min *1. “MUNICH–(BUSINESS WIRE)–XClinical, Continue Reading
COMMENTS: Good story on use of RWE / RWR in oncology. READ TIME: 2 mins *1. “Sir Mick Peake, clinical director for the Centre for Cancer Outcomes within UCLH’s Cancer Continue Reading
CONTEXT: Real world research showing value in rare disease research where RCTs cannot generate the statistical power traditionally needed with so few available patients. New methods to interpret the RWD Continue Reading
Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading
EXPERT NOTES: CONTEXT: EU, Commercial RWD Data Source IMPACT: Access to EU RWD, drive cutting edge improvements in patient outcome Time Taken = 3 mins QUOTES FROM SOURCE: 1. “NEW Continue Reading
EXPERT NOTES: CONTEXT: Decentralized Clinical Trials IMPACT: Enabling technology for ‘Decentralized Clinical Trials’ a.k.a ‘Virtual Trials’ Time Taken = 2 mins QUOTES FROM SOURCE: 1. “As mentioned earlier, COVID-19 has Continue Reading
Quick Notes: CONTEXT: Japan, Real-World Data IMPACT: Acceptability of RWD in Regulatory Submissions Time to Read = 2 mins Quotes from Source: 1. “TOKYO — Japan’s health ministry will issue Continue Reading
Quick Notes: *Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is Continue Reading
