View source for Talk:Clinical trial/Archive 1

{{talkarchive}}

== Cut and paste archive of some old stuff from the talk page ==

[[User:64.214.78.98|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

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ATTENTION: Who may help me TO CONTACT PAUL144?

Paul144 has removed the two lines of "Compassionate use trial" which I have added yesterday (26 Aug 2008) and replaced it by a US (FDA)(-related definition.)
It is true that the definition of "Compassionate use trial" varies in different countries and it is good to have his/her definition for the US but this is too narrow. The typical problem in Compassionate use trials is the problem of ethical conduct.  Therefore the sequential estimation of odds and the problem of optimal stopping is important. Since the [[Odds algorithm]] may be the only proven "optimal" policy
(Annals of Probability, 2000, pp 1384-1391) in this respect, it should definitely be referenced
-----------------------------------------------------------------------------  <small>—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[Special:Contributions/164.15.127.79|164.15.127.79]] ([[User talk:164.15.127.79|talk]]) 13:40, 27 August 2008 (UTC)</small><!-- Template:UnsignedIP --> <!--Autosigned by SineBot-->

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?--[[User:Polyparadigm|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. --[[User:Wouterstomp|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. --StudentForever[[User:128.104.94.51|128.104.94.51]] 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. [[User:72.208.56.148|72.208.56.148]] 17:51, 8 July 2007 (UTC)

&mdash;'''''[[User:G716|<span style="color:Purple;">G716</span>]]'''''&nbsp;&lt;[[User talk:G716|<sup>T</sup>]]·[[Special:Contributions/G716|<sub>C</sub>]]&gt; 03:54, 23 October 2008 (UTC)

== 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. --[[User:Cvanhasselt|Chris van Hasselt]] 14:20, 10 May 2006 (UTC)

== 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! :-) [[User:Keesiewonder|Keesiewonder]] 13:02, 23 November 2006 (UTC)

== Regulatory authority ==

I combined the growing [[WP:Laundry|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? [[User:Burlywood|Burlywood]] 15:57, 27 March 2007 (UTC)

== Sponsors ==

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

== How to find a clinical trial ==

This entire section moved from [[ATRT]], needs cleanup. [[User:Una Smith|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? [[User:Burlywood|Burlywood]] 20:38, 25 June 2007 (UTC)

== 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.  [[User:LtDonny|LtDonny]] 05:02, 15 July 2007 (UTC)

== 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. [[User:Linas|linas]] 16:29, 15 July 2007 (UTC)

== 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.[[User:Sofia Roberts|Sofia Roberts]] 05:21, 26 August 2007 (UTC)

== 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  <small>—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[Special:Contributions/83.196.113.98|83.196.113.98]] ([[User talk:83.196.113.98|talk]]) 15:51, 19 September 2007 (UTC)</small><!-- Template:UnsignedIP --> <!--Autosigned by SineBot-->

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. [[User:Sofia Roberts|Sofia Roberts]] 15:59, 29 September 2007 (UTC)

== 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.[[User:Sofia Roberts|Sofia Roberts]] 15:37, 30 September 2007 (UTC)

== 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. [[User:Arhardy|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. [[User:Sofia Roberts|Sofia Roberts]] 19:50, 17 October 2007 (UTC)

== 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?  <small>—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[User:OncoAnalyst|OncoAnalyst]] ([[User talk:OncoAnalyst|talk]] • [[Special:Contributions/OncoAnalyst|contribs]]) 18:56, 7 April 2008 (UTC)</small><!-- Template:Unsigned --> <!--Autosigned by SineBot-->
== 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.

21:35, 4 October 2008 (UTC)

== Study Design ==

This article mentions "double-blind", "double-dummy", and "cross-over" studies. There is some discussion in this article about what these terms mean, and also in the Wikipedia article "[[Crossover study]]". However, based on my reading of these articles, there is some uncertainty in my mind about what the exact difference is between "double-dummy" and "cross-over" studies. I am fairly certain that they are not synonymous, since the titles of some clinical trials use both of these terms. -- tdh  <small>—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[User:Thomas.Hedden|Thomas.Hedden]] ([[User talk:Thomas.Hedden|talk]] • [[Special:Contributions/Thomas.Hedden|contribs]]) 00:11, 18 August 2008 (UTC)</small><!-- Template:Unsigned --> <!--Autosigned by SineBot-->
== 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... [[User:Arhardy|Arhardy]]

01:10, 5 October 2008 (UTC)

== Should there be a section for potential participants? ==

Although Wikipedia is an encyclopedia, there have been more than a few attempts to include information useful to potential participants in this article. Such information would cover how to find clinical trials, how to choose one that is suitable, what to ask your doctor, etc. Should we even touch on this information (of course without providing specifics), or we continue to omit it? [[User:Sofia Roberts|Sofia Roberts]] ([[User talk:Sofia Roberts|talk]]) 16:34, 18 June 2008 (UTC)
== Restriction to participation in Phase-I ==

Are females restricted to participate in Phase-I clinical trials? I read it in one of the world's Leading CRO's training module. Is it so? Please let me have your views!  <small>—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[User:CRA1116|CRA1116]] ([[User talk:CRA1116|talk]] • [[Special:Contributions/CRA1116|contribs]]) 06:03, 7 August 2008 (UTC)</small><!-- Template:Unsigned --> <!--Autosigned by SineBot-->

== informed consent for clinical trials ==

does the clinical  on the patient without knowing or by knowing to them....  <span style="font-size: smaller;" class="autosigned">—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[Special:Contributions/122.167.109.14|122.167.109.14]] ([[User talk:122.167.109.14|talk]]) 13:57, 26 October 2008 (UTC)</span><!-- Template:UnsignedIP --> <!--Autosigned by SineBot-->

:An essential component of recruiting people into clinical trials is called "[[informed consent]]" explained at the NIH Clinicaltrials.gov website,[http://clinicaltrials.gov/ct2/info/understand] and below

:'''What is informed consent?'''

:"Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then '''the research team provides an informed consent document that includes details about the study''', such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The '''participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time'''." --[[User:Paul144|Paul144]] ([[User talk:Paul144|talk]]) 15:31, 26 October 2008 (UTC)
== Readability of this article ==

Contributors, please remember that we don't need to explain clinical trials to research professionals. We need to explain them to the general public. Please use short sentences and simple language. Put specialized information in footnotes or leave it out. It's more important for this article to be usable by the general public (and it's already very long) than for it to mention every issue facing the professionals involved in clinical trials. [[User:Sofia Roberts|Sofia Roberts]] ([[User talk:Sofia Roberts|talk]]) 01:31, 4 December 2008 (UTC)

== addition of subsection on placebo-controlled trials ==

The section former upon [[Placebo-controlled studies]] in [[Placebo]] has been move into a new article. It had been suggested that it should be incorporated into the design section here. I have put a wikilink and a brief summary to the new page in the design section. I have done this more in regard to the earlier suggestion that this text is moved here than anything else. It could well be rewritten or removed since it raises issues that are discussed earlier on this page. --[[User:LittleHow|LittleHow]] ([[User talk:LittleHow|talk]]) 11:44, 9 January 2009 (UTC)
== Merge proposal ==

{{Discussion top}}
Stub at [[Online clinical trial]] seems to have too little info to stand alone, but perhaps merits a mention in this article. [[User:PamD|PamD]] ([[User talk:PamD|talk]]) 12:04, 14 February 2009 (UTC)
:Agree. &mdash;'''''[[User:G716|<span style="color:Purple;">G716</span>]]'''''&nbsp;&lt;[[User talk:G716|<sup>T</sup>]]·[[Special:Contributions/G716|<sub>C</sub>]]&gt; 14:35, 23 February 2009 (UTC)
:Agree. [[User:Sofia Roberts|Sofia Roberts]] ([[User talk:Sofia Roberts|talk]]) 23:59, 23 February 2009 (UTC)
::Done &mdash;'''''[[User:G716|<span style="color:Purple;">G716</span>]]'''''&nbsp;&lt;[[User talk:G716|<sup>T</sup>]]·[[Special:Contributions/G716|<sub>C</sub>]]&gt; 01:28, 1 April 2009 (UTC)
{{Discussion bottom}}
== Readability of this article REVISITED ==

Contributors, please refer to my comments above. The article is starting to need extensive editing again. Please think about where in the article your information is most appropriate. Especially, the introduction section has to be totally rewritten so that the ordinary reader isn't defeated by jargon in the first paragraph. [[User:Sofia Roberts|Sofia Roberts]] ([[User talk:Sofia Roberts|talk]]) 04:04, 5 May 2009 (UTC)
== Ethics section ==

Suggest having an ethics section - the current ethical conduct only really covers what is appropriate and not really the ethics themselves. [[user:leevanjackson|L&there4;V]] 11:21, 30 July 2009 (UTC)

== medical device clinical trials ==

This clinical trial discussion focuses on drugs only. It would benefit from addition of a section on medical device trial.  <span style="font-size: smaller;" class="autosigned">—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[Special:Contributions/64.80.118.250|64.80.118.250]] ([[User talk:64.80.118.250|talk]]) 16:37, 14 August 2009 (UTC)</span><!-- Template:UnsignedIP --> <!--Autosigned by SineBot-->

The article also does not cover other types of interventions, e.g. behavioral interventions, rehabilitation strategies, effects of policy changes, etc. --[[User:Statprof|Statprof]] ([[User talk:Statprof|talk]]) 23:08, 23 August 2009 (UTC)
== Seasonal Trials ==

Interesting article on seasonal clinical trials. [http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Drug+Development/Flu-Season-Diseases-Affect-Trials/ArticleStandard/Article/detail/652128 Applied Clinical Trials Online: Flu, Season, Diseases Affect Trials]  -[[Special:Contributions/76.30.146.194|76.30.146.194]] ([[User talk:76.30.146.194|talk]]) 02:17, 10 February 2010 (UTC)

*This is interesting, there aren't many articles on seasonal trials. Thanks for sharing. I found the full version of this article is available here: (pdf) http://www.pharm-olam.com/pdfs/POI-Seasonality.pdf -[[User:Stevenmac4201|Stevenmac4201]] ([[User talk:Stevenmac4201|talk]]) 15:52, 20 February 2010 (UTC)

== Role of sponsor ==

In the UK (and elsewhere?) the sponsor does not necessarily provide financial backing for the clinical trial, particularly in academic research where a University may act as sponsor, but funding is supplied through a grant-awarding body.  By the way, this is a very well-written article.  [[User:Norman21|Norman21]] ([[User talk:Norman21|talk]]) 21:49, 20 February 2010 (UTC)
== Need glossary somewhere ==

clinical trials report using a very technical vocabulary.  eg significant, partial response, complete response, disease free progression, disease free survival.  Can we link to a glossary of these ? [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 12:52, 10 June 2010 (UTC)

== Misuse of sources ==

{{User|Jagged 85}} is one of the main contributors to Wikipedia (over 67,000 edits; he's ranked [[Wikipedia:List_of_Wikipedians_by_number_of_edits|198 in the number of edits]]), and practically all of his edits have to do with Islamic science, technology and philosophy. This editor has persistently [[Wikipedia:Requests for comment/Jagged 85/Evidence|misused sources here over several years]]. This editor's contributions are always well provided with citations, but examination of these sources often reveals either a blatant misrepresentation of those sources or a selective interpretation, going beyond any reasonable interpretation of the authors' intent. Please see: [[Wikipedia:Requests for comment/Jagged 85]]. The damage is so extensive that it is undermining Wikipedia's credibility as a source. I searched the page history, and found 6 edits by Jagged 85 (for example, see [http://en.wikipedia.org/enwiki/w/index.php?title=Clinical_trial&diff=169019864&oldid=168940704 this] [http://en.wikipedia.org/enwiki/w/index.php?title=Clinical_trial&diff=172160527&oldid=171706932 series] of [http://en.wikipedia.org/enwiki/w/index.php?title=Clinical_trial&diff=261596502&oldid=261422241 edits]). [[User:Tobby72|Tobby72]] ([[User talk:Tobby72|talk]]) 17:43, 18 June 2010 (UTC)
== Accidents ==

There are lots of accidents that happen with clinical trials, especially Phase 1, 0, POC, FIM, etc. studies. this section could be expanded. - [[Special:Contributions/206.126.56.131|206.126.56.131]] ([[User talk:206.126.56.131|talk]]) 18:50, 23 September 2010 (UTC)

Do all of the listed studies qualify as "accidents"? Isn't one of the reasons for performing a phase III study the need to collect data on side-effects that occur infrequently? [[User:Norman21|Norman21]] ([[User talk:Norman21|talk]]) 06:22, 20 October 2010 (UTC)

I agree with Norman21.  Since the goal of clinical trials is to find unknown and unintended effects of using these drugs one would have to think that actually finding such (for example massive organ failure) would count as the trial working correctly.  I think the accidents section should either be renamed to something indicating trials notable for poor outcomes or the accidents section should be restricted to cases where harm came about from failure to adhere to trial protocols.  In its current state I would just delete it because it seems to be just an arbitrary list of trials. [[User:Bobprime|Bobprime]] ([[User talk:Bobprime|talk]]) 21:27, 15 December 2010 (UTC)

== What is a pivotal trial ==

It seems to be the trial(s) that provides the final evidence to gain approval - ie normally a phase III trial, but for [[Orphan drug]]s it can be a Phase II trial (eg [http://checkorphan.getreelhealth.com/grid/news/treatment/ariad-announces-initiation-of-ponatinib-ap24534-pivotal-trial-in-drug-resistant-or-intolerant-chronic-myeloid-leukemia ]) ?  [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 12:08, 23 November 2010 (UTC)
== Mentioning ongoing clinical trials on Wikipedia pages? ==

I'm wondering what the general consensus - or for that matter, Wikipedia policy - is regarding having page sections describing ongoing clinical trials for given disorders and given drugs. Such trials are usually interested in recruiting patients, and although trials are listed on sites like clinicaltrials.gov I'd think having a mention of them in related Wikipedia articles could be useful. But is it appropriate?  <span style="font-size: smaller;" class="autosigned">—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[Special:Contributions/173.79.248.237|173.79.248.237]] ([[User talk:173.79.248.237|talk]]) 21:27, 16 September 2010 (UTC)</span><!-- Template:UnsignedIP --> <!--Autosigned by SineBot-->
:My opinion is that having an article called "List of ongoing clinical trials" or something similar would be a bad idea. Plus there are thousands of clinical trials. However, for a specific compound, drug, device, etc. that already has a wikipedia article, it would be a good idea to mention that it is currently in clinical trials (e.g. "''Drug A001'' is currently in a Phase III clinical trial to study the effectiveness of its use in ''indication A'') or something along those lines. -[[Special:Contributions/206.126.56.131|206.126.56.131]] ([[User talk:206.126.56.131|talk]]) 18:50, 23 September 2010 (UTC)
::Agreed. Also, specific trials could be cited to illustrate a particular type of study, e.g. crossover trial, phase I/II trial, etc. [[User:Norman21|Norman21]] ([[User talk:Norman21|talk]]) 06:05, 20 April 2011 (UTC)
:::Already done here: http://www.clinicaltrials.gov. [[Special:Contributions/46.138.95.18|46.138.95.18]] ([[User talk:46.138.95.18|talk]]) 16:31, 6 November 2011 (UTC)
::::There are some mega-trials which are notable in their own right. If anyone wants to talk about expanding coverage of clinical trials, ethics, or governance, then please contact me. [[User:Bluerasberry|<span style="background:#cedff2;color:#11e">''' Blue Rasberry '''</span>]][[User talk:Bluerasberry|<span style="cursor:help"><span style="background:#cedff2;color:#11e">(talk)</span></span>]] 16:06, 23 December 2011 (UTC)

== Revision of phrase "side effect" ==

In clinical pharmacology, specifically Phase I with first in human studies, the term side effects is frowned upon.  This is because these observations cannot be directly tied to the trial itself.  Instead, the phrase "adverse event" is accepted and used by the industry to describe any event that is unwanted, observable, and documented.  The phrase side effect promotes a relationship between the event and the drug; often times there may be none.  Suggest changing all instances of "side effect" to "adverse event."  <small><span class="autosigned">—Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[User:Rwking2|Rwking2]] ([[User talk:Rwking2|talk]] • [[Special:Contributions/Rwking2|contribs]]) 04:08, 3 December 2010 (UTC)</span></small><!-- Template:Unsigned --> <!--Autosigned by SineBot-->
:Good idea.[[User:Norman21|Norman21]] ([[User talk:Norman21|talk]]) 15:40, 3 December 2010 (UTC)

A problem I see with this idea is that, particularly with psychopharmaceuticals, a side effect may be what's causing the claimed efficacy, i.e., not technically "adverse".

Oddly enough, I see nothing in the article about how a clinical trial for any psychopharmaceutical can be deemed a valid trial if the drug, the control, and the placebo do not have identical side effects (not just adverse effects). In such a "trial", even if the results are not "rigged" (e.g., by excluding people who are known to not respond to the control, and by not including people who drop out of the trials due to serious adverse side effects or due to lack of perceived improvement), any statistically significant improvement could be caused by the drug, by any one of the side effects (e.g., something that affects memory or makes someone feel physically lousy could help against depression), or by the placebo effect (anyone who experiences any side effect that's new to them will know they are receiving the drug or the control and not the placebo, and knowing they're being treated is often the cause of the placbo effect in a patient). In other words, if there's now way of knowing what's causing the statistically significant improvement, a trial to show efficacy can't do so, and a double-blind trial in which a patient could fairly easily guess if they're getting a placebo would not be a blind trial.

[[User:KMLion|KMLion]] ([[User talk:KMLion|talk]]) 21:16, 12 November 2011 (UTC)

== Deletion of "Information Technology" Section ==

I don't think that the "Information Technology" section really contributes anything to the article. It says nothing of use and makes this very long article even longer. What do you all think?[[User:RobertHannah89|RobertHannah89]] ([[User talk:RobertHannah89|talk]])  <span style="font-size: smaller;" class="autosigned">—Preceding [[Wikipedia:Signatures|undated]] comment added 05:13, 27 January 2011 (UTC).</span><!--Template:Undated--> <!--Autosigned by SineBot-->

== Misuse of sources ==

This article has been edited by a user who is known to have misused sources to unduly promote certain views (see [[WP:Jagged 85 cleanup]]). Examination of the sources used by this editor often reveals that the sources have been selectively interpreted or blatantly misrepresented, going beyond any reasonable interpretation of the authors' intent.

Please help by viewing the entry for this article shown at the [http://en.wikipedia.org/wiki/Wikipedia_talk:Requests_for_comment/Jagged_85/Cleanup5 page], and check the edits to ensure that any claims are valid, and that any references do in fact verify what is claimed. 

I searched the page history, and found 6 edits by Jagged 85 (for example, see [http://en.wikipedia.org/enwiki/w/index.php?title=&diff=prev&oldid=169019864 this] [http://en.wikipedia.org/enwiki/w/index.php?title=&diff=prev&oldid=172160527 series] of [http://en.wikipedia.org/enwiki/w/index.php?title=&diff=prev&oldid=261596502 edits]). [[User:Tobby72|Tobby72]] ([[User talk:Tobby72|talk]]) 19:02, 19 January 2012 (UTC)

== What does t123 mean? ==

The last line of the History section reads "this organization collected data from physicians practicing outside the hospital setting and was the precursor of modern collaborative clinical trials and t123" What does "and t123" mean? It doesn't appear in the same quote in the article about
[[Frederick Akbar Mahomed]] - is it just a typo? <span style="text-shadow:grey 0.2em 0.2em 0.1em; class=texhtml">[[User:Richerman|<span style="color:green;">Richerman</span>'']]</span>   [[User talk:Richerman|'''(talk)''']] 00:05, 13 October 2013 (UTC)

== Multi-arm trials ==

I can't see [http://www.insight.mrc.ac.uk/2014/07/25/clinical-trials-why-multi-arms-are-better-than-two/ this type] is covered, here or elsewhere. [[User:Wiki CRUK John|Wiki CRUK John]] ([[User talk:Wiki CRUK John|talk]]) 12:06, 5 August 2014 (UTC)

== Independent Clinical Trial ==

My name is Paola Mosconi, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, IRFMN, Italy, coordinator of the ECRAN project on behalf of the ECRAN partners (http://www.ecranproject.eu/en/content/partners). As during the project we have depoloved a lot of materials and tools regarding clinical trials we would like to improve some Wikipedia entries related to clinical and medical research. We tried to create the new entry "independence clinical trial" but you delete it. The aim is to underline the concept of independence in clinical trial. So, we can create a new entry or improve the pre-existing “clinical trial”. Can you suggest me how to do it according to your guidelines?  <small><span class="autosigned">—&nbsp;Preceding [[Wikipedia:Signatures|unsigned]] comment added by [[User:DeboraSerra|DeboraSerra]] ([[User talk:DeboraSerra|talk]] • [[Special:Contributions/DeboraSerra|contribs]]) 09:15, 4 August 2014 (UTC)</span></small><!-- Template:Unsigned --> <!--Autosigned by SineBot-->
: What is the concept of independence in clinical trial ? Is it related to design or ethics or administration ? How would you propose to change the existing article ? - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:20, 30 October 2014 (UTC)

== Should observational studies be here? ==

In the "Types" section there is mention of "observational studies". They are important, but are they really "trials"? [[User:Norman21|Norman21]] ([[User talk:Norman21|talk]]) 06:02, 20 April 2011 (UTC)


I would also like to challenge the subsumption of the term "observational study" under "clinical trial":
A trial has always attributes of a test. A "subject" undergoes a "(clinical) trial". In contrast, an "observational study" avoids any interference with the observed "object" or population.
Thus, I would use the term "clinical trial" exclusively for studies which have (at least partly) an interventional character.
A "study" which solely observes persons/objects/procedures/etc. in their normal environment and does not influence them by any means should not be called "trial".
A trial can be named a study. However, a study does not necessarily need to be a trial.
[[Special:Contributions/196.3.50.254|196.3.50.254]] ([[User talk:196.3.50.254|talk]]) 21:42, 19 February 2014 (UTC)
: Yes, but Sadly at the moment [[clinical study]] just redirects to this [[clinical trial]]. Perhaps it should be the other way around ? or clinical study could disambiguate between clinical trial and [[observational study]] ?- [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:29, 30 October 2014 (UTC)

== What is a pivotal trial ==

Many trials are referred to as 'pivotal'.  Can someone explain what this means plesae.  My understanding/guess is that it is a trial expected to provide evidence for an NDA or similar marketing authorisation - normally a phase 3 trial but sometimes (eg for orphan indications) it can be a phase 2 trial. Is this true ? or what does it mean ? - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:00, 30 October 2014 (UTC)
:you got it.  the phrase is most often used with medical devices, which don't have the PhI/PhII,PhIII structure - instead they have "feasibility studies" and then they go the "pivotal trial" to get data for approval.  it is sometimes used of drugs too. [[User:Jytdog|Jytdog]] ([[User talk:Jytdog|talk]]) 11:24, 30 October 2014 (UTC)
::: see [http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm373750.htm here] and [http://circ.ahajournals.org/content/119/13/1694.full here]. [[User:Jytdog|Jytdog]] ([[User talk:Jytdog|talk]]) 11:27, 30 October 2014 (UTC)
::: Many thanks. Your 2nd ref says "...pivotal trial (ie, the trial that will be used to make specific claims about efficacy and safety)." Could be mentioned in the overview ? - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:47, 30 October 2014 (UTC)

== Scenarios poorly suited to standard commercial clinical trials ==

{{ping|FT2}} I propose removal of this entire section as it is mostly [[WP:OR]]. The subsections include:
# Compassion use - most often used for drugs that are in early stages of development and WILL be the subject of a clinical trial in the disease in question at a later date. And legally, compassion use is a clinical trial with a single patient, at least in the U.S.  So the text is incorrect and cites a source that does not directly support this section.
# Difficulty in obtaining suitable trial populations for usual trials - broken into "rare conditions" and "Harm due to Placebo" - again, mostly unsourced.  Rare conditions are not really a problem unless the condition is unimaginably rare.  They are almost easier because they are cared for by a limited number of specialist physicians, and if you find the physicians, you can find the patients.  Trials have been performed in conditions in which there are only about 1000 people worldwide.  Similarly, there is no problem doing a trial in a condition in which placebo would be harmful.  You just use an active control. Every antibiotic approved in the last 50 years was tested that way.
# Difficulty of scaling production and Economic disincentives are problems for drug development overall, but not specifically to clinical trials.  And both sections are completely unsourced.
# Serousness of an outbreak.  This is all original research citing the Ebola outbreak as an example. But there are currently two ongoing Ebola clinical trials in Africa.  

[[User:Formerly 98|Formerly 98]] ([[User talk:Formerly 98|talk]]) 16:58, 17 November 2014 (UTC)

== Device Research? ==

By ignoring the requirements of device research, readers are being misled.  This article speaks only to drug research, not device or biological research.  I recommend some caveats.  I suggest removing the Phases of a study, since they don't apply to device research.  They can be included in a separate article. --[[User:Eddylyons|Eddylyons]] ([[User talk:Eddylyons|talk]]) 18:11, 1 July 2013 (UTC)
: Probably easier to leave phases here and refer to a new article for [[clinical trials of devices]] ? - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:39, 30 October 2014 (UTC)
:: Strongly disagree. All of the regulatory, monitoring, training etc. procedures for device studies are the same as for drug studies. A device section can just concentrate on how device studies are different from drug studies. [[User:Sofia Roberts|Sofia Roberts]] ([[User talk:Sofia Roberts|talk]]) 17:07, 11 March 2015 (UTC)

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:Requires a new reference which I will add. --[[User:Zefr|Zefr]] ([[User talk:Zefr|talk]]) 16:53, 26 November 2016 (UTC)

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:Source can be better. Will insert into article. --[[User:Zefr|Zefr]] ([[User talk:Zefr|talk]]) 14:02, 9 August 2017 (UTC)

== Could mention Basket studies ==

Article does not mention Basket studies.  [http://www.pharmacypracticenews.com/FDA-Approvals/Article/11-17/FDA-Approves-First-Treatment-for-Erdheim-Chester-Disease/45182/ ] says "Basket studies use an innovative clinical trial design that helps collect data faster, and may accelerate the development of medicines for diseases with high unmet need. Instead of enrolling people based primarily on their disease or its location, basket studies match a disease’s underlying genetic profile to the mechanism of action of the medicine." Seems worth mentioning. - [http://www.cancertherapyadvisor.com/general-oncology/cancer-basket-trials-advantages-limitations/article/629724/] is more detailed. ~ RS ? ... [http://ascopubs.org/doi/full/10.1200/JCO.2016.69.9751 ''Basket Trials in Oncology: A Trade-Off Between Complexity and Efficiency''] compares them to Umbrella trials. - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:44, 11 November 2017 (UTC)
: Should probably put in [[Clinical study design]] first. - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 11:53, 11 November 2017 (UTC)

== Detail removed from Active control studies ==

As it seemed to be excessive detail/promo for this article, (and was unsourced). I removed the following from ''Active control studies''. 
:"A growing trend in the pharmacology field involves the use of third-party contractors to obtain the required comparator compounds. Such third parties provide expertise in the logistics of obtaining, storing, and shipping the comparators. As an advantage to the manufacturer of the comparator compounds, a well-established comparator sourcing agency can alleviate the problem of [[parallel import]]ing (importing a patented compound for sale in a country outside the patenting agency's sphere of influence).{{Citation needed|date=March 2010}}" Maybe it could be used elsewhere. - [[User:Rod57|Rod57]] ([[User talk:Rod57|talk]]) 12:32, 11 November 2017 (UTC)

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== Regarding the "first proper clinical trial" in the History section ==

Hello all,

I was shown this historical research article that discussed the figure of Rhazes:https://www.researchgate.net/publication/322989401_Rhazes_a_pioneer_in_contribution_to_trials_in_medical_practice

It includes historical evidence that Rhazes was using clinical trials with control groups as early as 900 A.D., yet I see no mention of him in the historical section of this page. The "first proper clinical trial" is attributed to James Lind in 1747, but wouldn't it be more correct to say that it is only the first recorded instance in the West? I think this page would benefit by including Rhazes and his contribution to the concept of clinical trials.

I do not believe I am qualified to edit this page (my historical knowledge is poor), but I would appreciate it if someone could take the time to edit this page.

Thank you!

[[User:Amiguello|Amiguello]] ([[User talk:Amiguello|talk]]) 20:07, 1 June 2018 (UTC)