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Clinical study vs. clinical trial

Added by: Ekaterina Chashnikova
December 29, 2024

The terms clinical study and clinical trial can seem synonymous, but is it always the case? Let's see how regulatory authorities interpret these terms. It is important for medical writers and translators to understand the distinctions between these terms to use them correctly and consistently.

Regulatory definitions

According to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance:

✒️ ‘Clinical study’ means any investigation in relation to humans intended:
(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;

(b) to identify any adverse reactions to one or more medicinal products; or
(с) to study the absorption, distribution, metabolism and excretion of one or more medicinal products;
with the objective of ascertaining the safety and/or efficacy of those medicinal products;

Basically, it means that a clinical study is conducted to investigate the safety or efficacy of one or more drug products by studying their desirable or undesirable effects or their pharmacokinetics. Also, note that the definition mentions all medicinal products, not only the investigational ones.

The same regulation also states that clinical studies can be non-interventional, like observational studies.

What about clinical trial?

✒️ ‘Clinical trial’ means a clinical study which fulfils any of the following conditions:
(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
(b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
(c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

So, clinical trials can involve experimental or investigational medicinal products, and they are always interventional. The interventions can include both treatment and diagnostic or monitoring procedures.

Interestingly, Good Clinical Practice treats the terms clinical study and clinical trial as synonyms.

✒️ Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

As for FDA and NIH, they use the term clinical research that covers both clinical trials and clinical studies. Clinical research also includes epidemiological studies, patient registries, genetic studies, and all other research involving human subjects. In general, FDA considers a "clinical trial" to be a clinical study (or clinical research) that involves an intervention and can involve investigational products.

Also, note that the term "clinical research" is often used as a synonym of "clinical trial" and "clinical study" in patient-facing documents in the clinical trial industry.

The terms "human study" and "study in humans" are synonyms of "clinical trial" and "clinical study," but they are not usually used in clinical-trial-oriented documents. They are more often used when describing different stages in the drug development process or in the scientific literature.

Conclusion

To recap, a clinical trial is always interventional and may involve an investigational medicinal product. A clinical study can be both interventional and non-interventional. Strictly speaking, if clinical research matches the criteria of a clinical trial, it should not be called a clinical study.

If you are a medical translator, research the local regulatory documents to establish the correct equivalents of clinical trial and clinical study (you might not have similar synonyms or the distinction between them in your language).

Image by Darko Stojanovic from Pixabay

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