Saturday, September 17, 2016
New Rules to push for published trial results!
I have ranted here many times about the sad number of trial results that are actually published, despite the fact that since 2007, scientists have been REQUIRED to publish results on Clinicaltrials.gov. Most recently here: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/08/medical-studies-in-children-go.html
New rules were published Friday that cover all the trials types whose results most be published - including behavioral studies as well as any that have NIH funding (That's tax payer dollars, y'all!) AND... researchers must publish the good, the bad, and the UGLY! Even if the drug doesn't cut it for treating folks...they have to admit that! To me that information is just as important as data showing drugs that are successful...and should be even more valuable to scientists! Additionally, researchers have to say how they are going to use their data from the start. No more massaging the data after the fact just to have something to say. And perhaps most importantly, when studies are regulated by the FDA, companies can face fines of up to $10,000 per DAY, if they fail to comply! (Not that this is a new ruling...but the NIH reports that it will start enforcing these fines if needed!)
Ratties give their lives for the information clinical trials provide. To say...It's about time!...is an understatement!
Here's a link to the NPR story: http://www.npr.org/sections/health-shots/2016/09/16/494231378/hhs-issues-new-rules-to-open-up-data-from-clinical-trials
Hang on ratties! Clinical trials are still a wild ride! - c