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 new guidelines next fiscal year aimed at helping new drugs get to market faster, by allowing pharmaceutical companies to use data from outside of clinical trials.”
2. “The health ministry will accept medical information for patients that have taken the drug in other settings, in place of, or as a supplement to, data on a placebo group.”
3. “The gold standard for clinical research is randomized double-blind controlled testing, in which one group of participants is given the drug and the other receives a placebo, and neither patients nor doctors know which is which.”
4. “Double-blind tests of the flu drug Avigan’s effectiveness against the coronavirus, for example, had trouble recruiting patients, as the treatment was available in other research settings without the risk of getting a placebo instead.”
5. “The U.S. Food and Drug Administration is conducting coronavirus-related research with an American life sciences company, using data from electronic health records and other sources to analyze treatments and complication risks.”