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In the "Types" section there is mention of "observational studies". They are important, but are they really "trials"? 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. 188.8.131.52 (talk) 21:42, 19 February 2014 (UTC)
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. --Eddylyons (talk) 18:11, 1 July 2013 (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. Sofia Roberts (talk) 17:07, 11 March 2015 (UTC)
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? — Preceding unsigned comment added by DeboraSerra (talk • contribs) 09:15, 4 August 2014 (UTC)
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 ? - Rod57 (talk) 11:20, 30 October 2014 (UTC)
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 ? - 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. Jytdog (talk) 11:24, 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 ? - Rod57 (talk) 11:47, 30 October 2014 (UTC)
Scenarios poorly suited to standard commercial clinical trials
@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.