Protected: The Facts and the Fictitious: Regulatory Drab
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Quick Notes: CONTEXT: Europe Healthcare IT Market, Market Forecast and Analysis IMPACT: Expansion of IoT in the Healthcare Field and promise of new and exciting strategies for upcoming products by Continue Reading
IMPACT: Preliminary RWE on effectiveness of single dose of Pfizer vaccine; 1st dose of the Pfizer vaccine seen to curb infection rates by 50% within 14 days; data from 800,000 Continue Reading
Comments – Part of the growing trend for big pharma to secure bid data sources for their own use. A move in the right direction towards ‘regulatory grade’ RWE. READ 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
IMPACT: The power of numbers…real-world data from 3.5 million vaccinated Israeli’s shows impact/ effectiveness of the Pfizer vaccine during early phase of roll out. READ TIME: 2 min *1. “Among 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
CONTEXT: FDA publishing an action plan on AI in SAAMDs. China already ahead of the game in terms of how they have already enacted guidance on AI in SAAMDs, but Continue Reading