Are we surprised??

[Gabes-Apg]

(you have to join the site (free) to see the article via the link... https://www.genomeweb.com/scan/slow-rep ... 15:00%20PM)


Slow to Report
Mar 12, 2015
Sponsors aren't reporting clinical trial data like they are supposed to, according to an analysis performed by Duke University researchers.

Part of the Food and Drug Administration Amendments Act requires sponsors to register their non-phase I clinical trials of drugs, medical devices, or biologics, and report basic summary results at ClinicalTrials.gov within a year of the completion of data collection.

As they report in the New England Journal of Medicine this week, Duke's Monique Anderson and her colleagues identified more than 13,300 clinical trials that ended between January 2008 and August 2012 that they deemed to be subject to that requirement.

About 13 percent of these trials, the researchers say, reported their results within 12 months and about 38 percent reported them within five years. Within that first year, 17 percent of trials funded by industry, 8 percent of trials funded by the National Institutes of Health, and almost 6 percent of trials funded by other government or academic institution reported their results. The median time to reporting was 17 months, the researchers add.

"We were really surprised to find that very few people are following the law," Anderson tells NPR.

There are, NPR adds, various reasons why investigators may be slow or hesitant to report results. They may simply be too busy, or they might not want to admit their trial didn't work.

Anderson and her colleagues note that penalties of $10,000 a day and a loss of NIH funding have been established for failing to submit results, but that has not been enforced as the rule has not yet been approved.

[DJ]

Failed trials are also informative. All trials should be reported as required. We are a society of procedures and laws but compliance and enforcement seems erratic.

I need to know if there are updates on the research done on cow flatus. I want to be the first to invest in cow mufflers or cow HEPA filters. Why have we not heard anything lately? I smell insider trading!

[tex]

I'm not sure that mufflers or HEPA filters would be effective enough against gas for them to be approved for that use by the EPA. I'm thinking more along the lines of an afterburner. They work pretty well on diesel engines, but the problem is that they would cost more than the cow is worth. Of course that wouldn't matter to the EPA.

Drug laws in this country are only enforced against citizens, not pharmaceutical companies, because Big Pharma has money and therefore plenty of political clout, and everyone knows that taxpayers always end up paying the bill anyway.

Tex

[DJ]

I'm having a vision of a supersonic cow flying over the moon. How can this circle back to misuse of research money? Maybe supersonic cows could catch the attention of society by wearing banners.
Research is one example of the bazillion things that are not what they appear to be (said the cranky woman with a bladder infection).

[tex]

I'm having a vision of a supersonic cow flying over the moon. How can this circle back to misuse of research money? Maybe supersonic cows could catch the attention of society by wearing banners.

There's plenty of money to be made in advertising. And just think of all the excited kids when they see the old nursery rhyme line about the cow jumping over the moon actually brought to life.

Tex

[DJ]