trial rgistries for transparency not working
 

http://www.the-scientist.com/blog/display/55953/

Trial registries not working Posted by Alla Katsnelson

Clinical trial registries -- set up in the last few years to ensure trial data see the light of day -- are a long ways from correcting the problem, says a report to be published in the Journal of the American Medical Association (JAMA) tomorrow (September 2).



"This sort of evidence is disappointing, I think," said Ian Roberts, a professor of epidemiology and public health at the London School of Hygiene and Tropical Medicine ...there is a lack of implementation and enforcement" in registering trials in such databases.

Clinical trial registries were one solution proposed to fight what's known as publication bias, or when trial sponsors fail to publish negative data. For instance, sometimes an original outcome measure will fail to show an effect of a treatment, so the trial sponsors publish the trial using another measure, which did show a positive effect, as the primary outcome -- raising concerns that data from that original outcome may not even make it into the published report.

"We bring all the evidence of randomized controlled trials together and if there are [such] biases, we could get the answer wrong," Parker said. "People could really suffer."

In 2005, the International Committee of Medical Journal Editors, whose members work at prominent journals such as the British Medical Journal, The Lancet, and JAMA, began requiring trial investigators to register trials -- including the primary outcome measures -- in any of several existing databases before publishing the data. Registering trials is now the norm, but it doesn't seem to have fixed the problem of publication bias.

Philippe Ravaud, a professor of epidemiology at Paris Diderot University in France, and his colleagues chose 323 randomized controlled trials (RCTs) relating to three disease areas ...Just 45% of the published trials were properly registered, they found -- that is, registered before publication and spelling out the trial's primary outcomes. The others listed vague primary outcomes, or none at all. But even within those registered properly, 31% switched the primary outcome. In some cases, the article's primary outcome was the secondary outcome in the registry, or not listed in the registry at all; in others, the registered primary outcome was not included in the article.



Last year, Roberts and his colleagues published a similar study on 75 clinical trials submitted to The Lancet, which requires researchers to submit the original trial protocols before publication. Even in that journal, said Roberts, 11 of the 37 trials they examined showed major discrepancies in the primary outcomes stated in the protocols and the published studies. It's a problem, said Roberts, "but what's less clear is whose responsibility it is to fix it."

Just exactly what do these people think they are doing? What right do they have to think they can play games with our lives?
The simplest common sense and the simplest human decency should tell them that withholding or falsifying scientific information about medical care is something that you just don't do. How can anyone be in the medical field and have so little affection for people? Some of these researchers are clearly in the wrong line of work, and a few of them are on the wrong side of the door of a prison cell.
signed, Bob Dawson

Junior Amgens in training
 

Not much wonder it gets as unethical and crude as the Amgen GDNF scandal. Sounds like they learn how to get away with science fraud and lies and dishonesty right from college days.

“11 of the 37 trials they examined showed major discrepancies in the primary outcomes stated in the protocols and the published studies.”
Translation: they threw away the true results of their scientific research and typed up a batch of lies that they thought they could sell on the marketplace or trade for comfortable tenure.

“Just 45% of the published trials were properly registered” So more than half have something to hide. Or keeping it all themselves. Or too lazy to bother.

“The others listed vague primary outcomes, or none at all.”
They have something to hide in the primary outcomes. Science fraud.

“But even within those registered properly, 31% switched the primary outcome. In some cases, the article's primary outcome was the secondary outcome in the registry, or not listed in the registry at all; in others, the registered primary outcome was not included in the article.”
Okay, now read that last paragraph over about ten times, photocopy it, and hand it out in your neurologist’s waiting room; better still, mail it to one of the many Parkinson’s associations and find out which ones put it in their newsletters. Read that again. This is medical research we are talking about. This is junior Amgen-land. Seems Amgen is right to think it is the routine procedure. In this science research to defeat disease, supported by taxpayers’ dollars and generous donors and high prices of drugs, “31% SWITCHED THE PRIMARY OUTCOME”.

Excuse me? Excuse me? You do medical research and you don’t like the results so you switch the primary outcome? Just who the “f…” do you think you are? We are getting beyond science fraud here; we seem to be wandering into blatently criminal territory.

“sometimes an original outcome measure will fail to show an effect of a treatment, so the trial sponsors publish the trial using another measure”
Well now there’s a good medical idea. Results no good? What the hell, stick in some other set of numbers.

“if there are [such] biases, we could get the answer wrong," Parker said. "People could really suffer." No kidding, Sherlock? Patients might suffer if the medical researchers deliberately hide some information and falsify the rest? Just an ignorant question from a whining peasant: Why aren’t some of these people in jail? Why aren’t the perps named? Why can’t we, the patients, have the list of the 31% of scientists who switched the primary outcome because the true results were not profitable? Name them! Name the studies the perps falsified! We get arrested DUI, our picture goes in the local newpaper; these perps lie about life-and-death information, and no one is even allowed to know who they are.

and they judge us
 

And they are the ones who study Parkinson's People and tell the world that 3 or 6 or 8 or 13% of us are gamblers and sex addicts and untrustworthy people. And THEY falsify 31% of the primary outcomes of their research.
And they judge us.