Talk:Phases of clinical research

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Sourcing problem[edit]

The sourcing is weak for this article. Does anyone have any book on the history of the development of these phases for clinical trials? Blue Rasberry (talk) 23:32, 14 January 2012 (UTC)

A lot of the article is also non-standard. I've never heard of Phase 0 and Phase V until seeing this article. Moreover "Phase zero" never includes human subjects for pharma trials. Once people are going to be involve it requires a investigational new drug application with the FDA and Phase I trials begin for safety and dosing determination in healthy volunteers. — Preceding unsigned comment added by (talk) 20:53, 2 October 2012 (UTC)

Agreed on Phase 0 and Phase 5 trials. Phase 5 in particular is a term that was proposed briefly in academia (see cited source) in the mid 2000's but is not used. Research along those lines is now more often referred to as real world evidence. No mention of Phase V is made on FDA or CenterWatch. Barring objections, I will remove shortly. Jacobhamza (talk) 12:14, 15 April 2015 (UTC)


I just made a table for this article. The information in the table is easy to source, but I actually took the information in it from multiple sources. I do not think the content it contains is debatable; it is a straightforward presentation of information. However, I think it would look sloppy to have the data sourced to different books or articles. Surely there is an explanation somewhere of the phases of clinical trials which presents a table just like this. Where is it? If the table needs to be justified by naming multiple sources which incidentally give this information, then I or anyone can do that, but I think there must be a source somewhere which presents a table just like this. Blue Rasberry (talk) 14:07, 10 March 2012 (UTC)

The table looks excellent but I think it would be fantastic if we could get a % failure rate in the table. I'm just having a hard time finding anything but phase II failure rates anywhere. If we can get rates for all phases, then we could put another column in here, which would be amazing. Overall i think the success rate of any pharm that enters phase one out to marketing is ~8%.Cpt ricard (talk) 01:37, 10 June 2013 (UTC)
dropping this here: Cpt ricard (talk) 02:11, 10 June 2013 (UTC)
Referencing multiple sources would not be problematic. Phase V definitely needs a source, and should be removed if one is not provided soon. The term 'Translational research' is typically taken to refer to the transition from basic research to either therapeutic or diagnostic outcomes at the clinic (see the linked Wikipedia article), and arguably includes other commercial outputs, such as products/processes for production or storage of cells. I am unaware of any context in which it could mean 'clinical trial phase V'. It's correct that this article is very much focused on standard pharmaceuticals, and is not wholly relevant to, for example, regenerative medicine, cell therapies etc. Jenks (talk) 13:24, 27 August 2014 (UTC)

Focus on pharmaceutical trials[edit]

The introduction indicates that this sort of system of trial phases would be used for any medical process which is proposed for widespread clinical application. But then like many articles it then focuses entirely on pharmaceutical use. When someone has time, the article should mention analogous trial phases for processes like surgery, radiotherapy or rehabilitation. — Preceding unsigned comment added by WeRegretToInform (talkcontribs) 08:36, 25 April 2014 (UTC)

Page listing Phase III clinical trials by year they took place =[edit]

Would there be interested, or would it be within the scope of Wikipedia, to have a page, tentatively called "List of Phase III clinical trials 2014", that would list trials in Phase III that started during 2014? The table could contain the compound, targeted disease/condition, company/group responsible and possibly starting date. — Preceding unsigned comment added by Avilella (talkcontribs) 11:45, 19 October 2014 (UTC)

Avilella I would like for Wikipedia to have mass coverage of clinical trials but this would not be easy to do. How do you propose to do what you say? Do you want to talk about automation or human creation of clinical trials lists? Blue Rasberry (talk) 12:19, 19 October 2014 (UTC)

I was thinking about starting with a simple Google Alerts and manually adding the entries that come from it. My interest is to do cancer initially, but we could open it up to all diseases if there are means, either manual or automated, to do so. The references are going to be the URLs of the news sources mentioning the Phase III trials. — Preceding unsigned comment added by Avilella (talkcontribs) 18:11, 19 October 2014 (UTC) Alternatively, we can start with FDA-approved drugs by taking the information from: — Preceding unsigned comment added by Avilella (talkcontribs) 18:20, 19 October 2014 (UTC)

Outcome Switching[edit]

Would it make sense to include into this article on Outcome Switching during clinical trials?


"American and European regulators require trials to be registered before they begin, complete with information about what they will be investigating and how they will go about it, so that researchers can check their colleagues have done what they promised to do. But enforcement is lax. A meta-analysis—a study of studies—published in BMC Medicine in 2015 found that 31% of clinical trials did not stick to the measurements they had planned to use. Another paper, published in PLOS ONE, also in 2015, examined 137 medical trials over a six-month period and found that 18% had altered their primary outcomes halfway through the trial, while 64% had done the same with secondary, less-important measures of success."

Shaded0 (talk) 16:33, 29 March 2016 (UTC)