Talk:Phases of clinical research/Archive 1

Archive 1

Sourcing problem

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)

On the subject of sourcing, does anyone have a citation regarding stage 3 clinical trials generally requiring two seperate studies? I have been unable to find a source on this anywhere.--Florid Psychosis (talk) 20:07, 19 December 2017 (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 130.68.20.187 (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)

For Defining Clinical study phases, I strongly recommend citation of International conference of harmonization, guidance E8, which was transformed into law by FDA, EMA and Japan PMDA. Link: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf. Wowbagger2 (talk) 16:54, 28 December 2017 (UTC)

Table

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: http://www.nature.com/nchembio/journal/v7/n6/fig_tab/nchembio.581_F2.html 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

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 (talk • contribs) 08:36, 25 April 2014 (UTC)

Page listing Phase III clinical trials by year they took place

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 (talk • contribs) 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 (talk • contribs) 18:11, 19 October 2014 (UTC) Alternatively, we can start with FDA-approved drugs by taking the information from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm — Preceding unsigned comment added by Avilella (talk • contribs) 18:20, 19 October 2014 (UTC)

I think these (proposed) pages wouldn't be worth the trouble. Would they include non-FDA trials in China, Mexico ... ? Who would be interested in the pages ? Wouldn't most people just use NIH-CT for the current situation ? Would it be year of registration, announcement, or first enrolment ? There are other websites listing trials that are recruiting. (The FDA pressannouncements page does mention drug approvals but does not seem to mention any/many clinical trials.) - Rod57 (talk) 09:33, 17 July 2017 (UTC)

@Rod57: We could have all of that. At CTTI Duke University provides a database containing all information about NIH's clinical trials. Eventually we on the wiki side have to import this or its equivalent into Wikidata. Yes, we also have to get the Chinese, Mexican, and other databases as well. Lots of people want this. It should be possible to search for any clinical trial by any parameter and Wikimedia projects are a natural place to both do this and build out Wikipedia articles on particular trials when anyone wants to do so. Blue Rasberry (talk) 18:12, 17 July 2017 (UTC)

• I don't see how this is encyclopedic per WP:NOTDIRECTORY and WP:NOTREPOSITORY. This is the purpose of clinicaltrials.gov and other trial registries, and they do a great job of that as far as i know. Might be a Wikidata project. Jytdog (talk) 18:14, 17 July 2017 (UTC)

@Jytdog: Yes, of course mostly Wikidata, but when a clinical trial becomes notable then it can have an article in Wikipedia. NIH and others do a poor job of cross-referencing clinical research with the non-academic press and the popular press has trouble identifying academic publishing on clinical trials which rise in public consciousness. I would not advocate for any change to Wikipedia's inclusion criteria at WP:N. Now is not the time to push the limits of NOTDIRECTORY and similar guidelines. Blue Rasberry (talk) 18:25, 17 July 2017 (UTC)

Outcome Switching

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

Ref: http://www.economist.com/news/science-and-technology/21695381-too-many-medical-trials-move-their-goalposts-halfway-through-new-initiative

"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)

Doesn't seem related to any specific phase - Could perhaps be mentioned in Clinical endpoint ? Presumably the FDA has to sanction changes to the primary endpoint(s) ? - Rod57 (talk) 09:48, 17 July 2017 (UTC)

Dubious clause in Phase IV

Phase IV says "or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials)." - I've marked it as dubious (for now) as it's unsourced and seems wrong. I believe trials to achieve additional indications would be phase II/III depending on design. - Perhaps the FDA define phase IV somewhere ? - Rod57 (talk) 09:11, 17 July 2017 (UTC)

What specifically do you regard as dubious? Once a drug is approved as safe and effective for one disease, and in Phase IV, other indications may be pursued, explained here. I revised the article on Ph. IV but perhaps we can improve it further. Thoughts? --Zefr (talk) 15:21, 17 July 2017 (UTC)

As I outlined in the talk page of accelerated approval, I do not agree with considering Phase IV studies to be regular required to convert an accelerated into a full approval. In most cases, this will be done via Phase 3 studies. Wowbagger2 (talk) 16:46, 28 December 2017 (UTC)

First-in-man

@Jytdog: – Do you want me to provide 100 references using the phrase "first-in-man"? The fact that you found a footnote saying that it's an outdated term doesn't mean it's just the politically correct opinion of that author. And. saying. things. like. this. isn't. civil. Natureium (talk) 03:26, 24 October 2017 (UTC)

Useful table of success rates

I've just added a link to Wong et al's 2019 analysis (Wong CH, Siah KW, Lo AW. Estimation of clinical trial success rates and related parameters. Biostatistics. 2019 Apr 1;20(2):273-86.), which includes a useful summary table. I lack the editing skills to create a table showing the findings; perhaps someone could take this on? Am sure readers would find it useful! Thanks Robma (talk) 11:28, 9 September 2020 (UTC)

@Wen D House: Interesting. I could set up a table but what data should we include? There is a lot here, too much to bring to this article.

This paper considers clinical trials. registered in the United States ClinicalTrials.gov, so I think it is not globally representative. I still think we could include it. Blue Rasberry (talk) 11:40, 9 September 2020 (UTC)