Clinical study

From Codex of clinical research

Clinical study (or clinical trial) – is scientifically designed experiment that involves human participants and evaluates outcomes of a medical intervention, such as new drug, treatment, or medical device. Clinical studies conducted to generate data that informs medical practice and healthcare decision-making.

Definitions

ICH E6(R2)

1.12 Clinical Trial/Study:
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. The terms clinical trial and clinical study are synonymous [1].

National Institutes of Health

Clinical Trial:
A research study [2] in which one or more human subjects [3] are prospectively assigned [4] to one or more interventions [5] (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes [6] [7].

EU Regulation

"Clinical study" means any investigation in relation to humans intended:

  1. to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
  2. to identify any adverse reactions to one or more medicinal products; or
  3. 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;

"Clinical trial" means a clinical study which fulfils any of the following conditions:

  1. 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;
  2. the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
  3. diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects [8].

Clinical trial vs study

A clinical trial is a subset of a clinical study, specifically focused on evaluating the safety and efficacy of a medical intervention. A clinical study is a broader concept that encompasses various research methodologies, including both interventional trials and observational studies.

See also

Another relevant pages

Links to this page

References

  1. ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
  2. ↑ See Common Rule definition of research at 45 CFR 46.102(l) https://www.ecfr.gov/current/title-45/part-46/section-46.102#p-46.102(l).
  3. ↑ See Common Rule definition of human subject at 45 CFR 46.102(e)(1) https://www.ecfr.gov/current/title-45/part-46/section-46.102#p-46.102(e)(1).
  4. ↑ The term prospectively assigned refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, other control) of a clinical trial. https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ProspectivelyAssigned
  5. ↑ An intervention is defined as a manipulation of the subject or the subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include drugs/small molecules/compounds, biologics, devices, procedures (e.g., surgical techniques), delivery systems (e.g., telemedicine, face-to-face interviews), strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits), treatment strategies, prevention strategies, and diagnostic strategies. https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#Intervention
  6. ↑ Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression), positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers, reading comprehension and/or information retention), positive or negative changes to disease processes, positive or negative changes to health-related behaviors, and positive or negative changes to quality of life. https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#HealthRelatedBiomedicalorBehavioralOutcome
  7. ↑ NIH, 2022, National Institutes of Health Glossary, https://grants.nih.gov/grants/glossary.htm#ClinicalTrial Accessed May 2024
  8. ↑ European Union, 2014, Regulation (EU) No 536/2014 of the European Parliament and of the Council, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32014R0536 Accessed Jun 2024

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