CONTEXT: Oncology news article on use of RWR in oncology. Nothing new in terms of data use, more confirmation of RWD in oncology research. However, an interesting perspective from the 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: Some people lost a small amount of weight whilst in a study….. Interesting thing here is the reporting of RWE data during a study lifetime, which has statistical penalties Continue Reading
CONTEXT: European initiative to explore “In-Silico” research. Not so much “Real World” as “Brave New World” utilising computer models to test safety and efficacy of medical devices. Hopefully this isn’t 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
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others 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
