Amgen Invests in Data Deal
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
Improving Oncology Outcomes with Data!
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
Israel’s Data and Determining Impact of Pfizer Vaccine
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
Ongoing NASH Study Discovers Weight Loss – Real World Research
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
“InSilicoTrials: accelerating the uptake of simulation in clinical research – Medical Device Network”
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
Real World Research example in rare disease use case
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
FDA: Plan for Oversight with ML/AI in Medical Devices
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
FDA & CBD: Filling Research Gaps with Real World Data
COMMENTS: Filling the gap between pharmaceutical grade cannabinoid derivative production through RWE. FDA will need to tighten up it’s response to CBD products with legal cannabis production booming in the Continue Reading
EMA to USE EMA Software for Real World Data
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
AMGEN INVESTS IN BIG DATA DEAL – REAL WORLD EVIDENCE
COMMENTS: Part of the growing trend for big pharma to secure bid data sources for their own use. IMPACT: A move in the right direction towards ‘regulatory grade’ RWE, READ Continue Reading