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 Cerivastatin and Vioxx were not withdrawn because of phase IV studies, though the impetus for Vioxx withdrawal was a clinical trial.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?

The article overall seems to bounce back and forth from clinical trials in general to cancer treatments, occasionally even wandering into the subject of children with cancer. A rewrite is probably needed, to stay on one topic. 72.208.56.148 17:51, 8 July 2007 (UTC)

Contents

[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)

[edit] Regulatory authority

I combined the growing laundry lists of regulatory authorities into a common footnote. I think that the long list of agencies was detracting from the main topic of this article and the list is bound to grow so that no one feels left out. My preference is to link a corresponding "Regulatory authority" article and drop the footnote, but the closest thing I can find is Category:Health ministries. Does anyone else have a suggestion? Is it even necessary to have a footnote with a long list of agencies? Burlywood 15:57, 27 March 2007 (UTC)

[edit] Sponsors

Someone who knows the ins and outs of this please explain how some clinical trials are NIH trials, others are private, others...? Una Smith 03:28, 24 June 2007 (UTC)

[edit] How to find a clinical trial

This entire section moved from ATRT, needs cleanup. Una Smith 03:28, 24 June 2007 (UTC)

I started by removing most of the links that were listed with the barest of explanation. The whole section is a how-to that is specifically prohibitted by WP:NOT. Wikipedia should not be giving medical advice. Is there any reason not to delete the whole section on this basis? Burlywood 20:38, 25 June 2007 (UTC)

[edit] Intro Section

I think there should be a rewrite of the introductory section to make it shorter. It just seems too long, and I feel that information such as the length of time it takes for cancer research, reasons for length of time, barriers, and other specific information should be incorporated into the body section of the article. LtDonny 05:02, 15 July 2007 (UTC)

[edit] small clinical trial

This article should mention that in common vernacular, "clinical trial" is often understood to refer only to Phase I, Phase II trials, i.e. with a small number of patients, typically reported by a single MD in clinical practice. This is in sharp contrast to large-scale (Phase III) studies, which, in common vernacular, are no longer "clinical", but are "large scale" instead. linas 16:29, 15 July 2007 (UTC)

[edit] Simplify!!

Yes, this is a comprehensive and mostly accurate page (except for implying that cancer is the only disease for which clinical trials are conducted.) But it is way beyond the comprehension of even college-educated people who are not already in the medical field. Pity the poor high-school student who comes to read this! Please, convert the jargon into English readable by a person with a 7th grade education, as is required by those who write informed consents.Sofia Roberts 05:21, 26 August 2007 (UTC)

[edit] Administration section

This section implies that most/all trials (now often called "studies") are conducted by 3rd party CROs. This is not the case, especially for larger pharma companies. Many trials are conducted all or in part by the sposoring company —Preceding unsigned comment added by 83.196.113.98 (talk) 15:51, 19 September 2007 (UTC)

Can you give some examples? All the clinical trials I have worked on that were sponsored by large pharmaceutical companies in the US employed CROs, even in the case of one company where the CRO seemed to work only for that company. Sofia Roberts 15:59, 29 September 2007 (UTC)

[edit] Request for additions and review

Hi everyone. I've done about as much as I can do with this page. I've created some new categories where additional information can be inserted. I think it needs a review by people with knowledge of psychological research, and pre-market medical device research. After that I'd like to see an administration review - it's changed a lot since it got a B rating.Sofia Roberts 15:37, 30 September 2007 (UTC)

[edit] Microdosing

Sorry to see no mention of Microdosing. Before I add a link to it from Phase 0 description, I want to give the author of this page the chance to comment. Arhardy 10:33, 17 October 2007 (GMT)

I'm not familiar at all with microdosing as my expertise is on Phase III and IV, and the concepts and administration of clinical trials in general, so anything else (Phase 0 and additions to the history and safety sections especially) could flesh it out. I should say I'm not the author of this page, only have done the last extensive edit. Sofia Roberts 19:50, 17 October 2007 (UTC)

[edit] Clinical Research vs Clinical Trial

I am not an author, just a user. I was redirected to this Clinical Trial page when I searched for clinical research (ironically, which I was searching to help define the relationship between clinical research and clinical trials). That might have been OK if you argue that all clinical research must be done in the form of a clinical trial, but not given the rather tight focus on drug-related clinical trials of this article. What about biomarker studies, epidemiological studies, or outcomes research? —Preceding unsigned comment added by OncoAnalyst (talk • contribs) 18:56, 7 April 2008 (UTC)


[edit] Adaptive Clinical Trials

I'm not qualified to add anything to the article about this, but might it be worth adding a few sentences on "Adaptive Clinical Trial" design? It seems to be a new and promising approach... Arhardy