Talk:Clinical trial

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64.214.78.98 16:08, 20 March 2006 (UTC)guest - Removed link to TGN1412 page, no other information listed. Info doesn't belong in the clinical trial article

Maybe someone should mention the controversy of having women or women of childbearing potential in clinical trials?

One of the requested pages is "open-label trial"...I redirected to this page, but there's not treatment of that term here yet. Maybe someone could add that?--Polyparadigm 12:13, 27 Feb 2005 (UTC)

I removed the following sentence from phase I studies: They are not blinded and there is usually no need for placebo control. I work for a Dutch pharmaceutical research company that does phase I studies, and almost all of them ARE double-blinded and placebo controlled. --WS 02:05, 25 July 2005 (UTC)

I'm new to Wikipedia, so I made some changes before I had a login, and before I knew all the rules of etiquette. Sorry everyone. Kudos to whomever wrote the article originally. In the first paragraph I added a link to the FDA since they are integral to most clinical trials, and added more detail about the most common types of clinical trials. I put the ethics section a new paragraph. I added a little more detail about the distinction between clinical trials and epidemiology, and added the epi link. Actually most clinical trials are not large and multi-center, so I added text to that effect, and also tried to clarify study power. I haven't gotten to the rest of the page, but of note, not all post-approval studies are phase IV, postmarketing surveillence is a distinct process. Cerivastatin and Vioxx were not withdrawn because of phase IV studies, though the impetus for Vioxx withdrawal was a clinical trial. I'll get to that when I can. I'm a year away from a PhD in clinical trials, so I'm thinking of lots of things to add in addition to the very good suggestions about open-label studies and women of child-bearing potential. --StudentForever128.104.94.51 15:40, 24 October 2005 (UTC)

Maybe someone could add how long each phase of a lcinical trial takes typically?

[edit] Definitions

In phase I clinical trials there are several terms that are sometimes confusing to the novice. These are

periods

groups

doses

Perhaps someone very experienced in Phase I clinical trials could explain these terms in some detail.

[edit] Links section

Is it necessary to include the link concerning research ethics for clinical trials in developing countries here? It seems appropriate to include this link in an article on research ethics, and then have a link here to a research ethics page, to me. I would make this change, but it is apparent that people with more knowledge than myself have worked on the article, so I'll leave it up to them to consider my question. --Chris van Hasselt 14:20, 10 May 2006 (UTC)

[edit] Phases - applies to medical devices too

Our article currently states "Before pharmaceutical companies start clinical trials on drugs, extensive pre-clinical studies are conducted." This is misleading since medical devices also go through the multi-phase trial process. I'll make edits when I get a chance ... unless someone else does a nice job before I do! :-) Keesiewonder 13:02, 23 November 2006 (UTC)

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