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Re: Clinical Trials Question? » denise1904

Posted by Larry Hoover on January 25, 2005, at 9:46:54

In reply to Clinical Trials Question?, posted by denise1904 on January 24, 2005, at 8:06:17

> Hi,
>
> Can somebody explain, when checking out the clinicaltrials.gov site, I often find studies (supposedly lasting less than 6 months) for which there are no results and the latest status seems to suggest that it's still going on.
>
> For instance I was checking out a study on Memantine (NCT00040261) which started June 2002. Phase 1 was for 8 weeks phase 2 was to take responders and put them into phase 3 for 16 weeks. Why is it that I can't find any results and why is it that the study seems to be ongoing. Am I not searching properly? Can somebody advise please?
>
>
>
> Thanks Denise.

Many, if not most, clinical trials are open-ended. When a doctor who is taking part in a clinical study comes across a potential candidate for the study, there is a process to determine more specifically if the candidate is eligible, and if they will consent to the study protocols. Some of the subjects will get a placebo, and many people aren't willing to take that chance.

Let's say the study is looking for 200 hundred participants.....it can take years to find all 200. The first subjects will have long since completed their participation, but they're still looking for others to build up the numbers to the 200 (or whatever) that they thought would be needed to give a statistically relevant result.

It's not like they have all 200 subjects all lined up at the same time, ready to go. It's dribs and drabs, one here, a handful there. Over time, enough data are collected to complete the study protocol. It can take years to find enough participants.

Lar

 

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poster:Larry Hoover thread:446678
URL: http://www.dr-bob.org/babble/20050124/msgs/447350.html