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Re: OLDSCHOOL: re drug trials, more:

Posted by OldSchool on March 31, 2002, at 22:20:52

In reply to OLDSCHOOL: re drug trials, more: OldSchool, posted by Janelle on March 31, 2002, at 21:17:58

> Well, first of all, where the heck is this Reboxetine available - Europe? Just curious. It apparently has gotten a lot of press here in the US, but the first I've heard of it is on this board.

yeah Europe. I know its available in the UK

> Second, you spoke of drug trials - what is the difference between a CLOSED trial and an OPEN trial? You said that in a closed trial you probably wouldn't reboxetine but a placebo instead. And you said that if it had been an open trial, you probably would have gone for it (meaning you would have had a better chance of getting reboxetine or you definitely would have gotten it?) Can you please explain the difference between a CLOSED and an OPEN trial? Thanks.

Sure. A closed trial is a clinical trial where you are "blinded." You dont know whether you are getting the real experimental drug (Reboxetine) or a placebo. This way the researchers supposedly get a more objective assessment of the effectiveness of Reboxetine. With a closed trial, usually you have about a one third chance of getting Reboxetine but you wont know if you got it til after the trial is over, where you are then "unblinded" and told what you got.

An "open" trial is where everything is out in the open from the beginning and you are guaranteed the real experimental drug or treatment. There are no placebos given. You have a 100% chance of getting the real experimental drug.

Most of the time in drug trials, they start out closed and blinded and as it progresses they start opening up open trials, where they test large numbers of people.

Like when I was in the rTMS clinical trials, initially I was in a closed trial, had no idea if I was getting real rTMS or not. Turned out I got placebo which I learned when I was unblinded. Not many months after I did my closed trial, the FDA gave permission to start "open" rTMS trials where you were guaranteed real rTMS.

Obviously open trial is the ideal situation if you want to try a new experimental drug or treatment.

> Third, you said that when Reboxetine was up for FDA review a year or two ago and everybody was excited about it that but it got rejected and the rumor was that Eli Lilly was trying to get some similar NE selective AD on the market and there was politics involved, so Reboxetine got blocked.
> I take it that Eli Lilly is NOT the manufacturer of Reboxetine, so which company is? Just curious.

I cant remember, I think its some British company if I remember right. No its definitely not Eli Lilly.

Old School




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