What is the difference between nonclinical and preclinical studies?
Thread poster: Roman Shchadnov

Roman Shchadnov
Russian Federation
Local time: 12:08
English to Russian
+ ...
Jan 21

As a medical translator, I was recently asked about the difference between two terms: “nonclinical study” and “preclinical study”. Unfortunately, I was not able to provide the answer, because I could not find any regulatory documents in which these terms were clearly separated.

As far as I can gather, these terms are very similar (both mainly refer to animal studies with a similar purpose), but the term “preclinical study” refers to a study performed before a first-in-man study, whereas the term “nonclinical study” refers to a study that can be performed both before a clinical study and alongside with it.

Am I right? Or there are other significant differences between them?


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Kaspars Melkis  Identity Verified
United Kingdom
Local time: 10:08
Member (2005)
English to Latvian
+ ...
they are the same thing Jan 21

I don't think there are any technical differences. Pre-clinical studies are so-called from the perspective of regulatory workflow and are needed to commence clinical trials. Whereas nonclinical studies are all those which do not involve human subjects. I can easily imagine them being performed outside the regulatory framework or at any time really.

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Nikki Scott-Despaigne  Identity Verified
Local time: 11:08
French to English
Suggestion Jan 21

On the one hand, I suspect that nonclinical studies are studies carried out without a specific intention for them to be the basis for a clinical study. On the other hand, I would suppose that pre-clinical studies are carried out with a view to their being specifically relevant to a particular clinical study.
Therefore, I think that these terms do probably not mean the same thing.

[Edited at 2018-01-21 12:55 GMT]


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Jacek Sierakowski
Belgium
Local time: 11:08
English to French
+ ...
In vitro vs in vivo Jan 21

Looks like non-clinical are in vitro, while pre-clinical are in vivo animal studies.
http://www.cobioscience.com/biobootcamp/preclinical_mcvean.pdf


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Anne Schulz
Germany
Local time: 11:08
English to German
For the EMA, they are the same Jan 21

The European Medicines Agency uses both terms interchangeably in their guidelines on pharmaceutical product informations. Whether or not there is a difference in the US, I don't know.

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Teresa Borges
Portugal
Local time: 10:08
Member (2007)
English to Portuguese
+ ...
Is this useful? Jan 21

Preclinical study: A study to test a drug, a procedure, or another medical treatment in animals. The aim of a preclinical study is to collect data in support of the safety of the new treatment. Preclinical studies are required before clinical trials in humans can be started.
https://www.medicinenet.com/script/main/art.asp?articlekey=5019

Nonclinical Study: Biomedical studies not performed on human subjects.
https://clinicaltrials.llu.edu/sites/clinicaltrials.llu.edu/files/docs/clinical-trial-terms-for-researchers.pdf

Also look at “Preclinical and Nonclinical Studies” in http://www.cobioscience.com/biobootcamp/preclinical_mcvean.pdf


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LEXpert  Identity Verified
United States
Local time: 04:08
Member (2008)
Croatian to English
+ ...
Different language versions of the EMA templates are inconsistent on this point Jan 21

It's easy to see how the confusion might arise, since the different language versions of the SmPC template seem to be inconsistent. For example, in the exact same passages:
EN template - Sec. 5.3 title refers to "Preclinical safety data" but in the subsequent text it's "non-clinical data".
HR (Croatian) template - Sec. 5.3 refers (in Croatian) to "Non-clinical safety data" in the title and "non-clinical data" in the text
DE template - Sec. 5.3 refers (in German) to "Preclinical safety data" in the title and to "preclinical data" in the text.

No wonder people are confused.


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