Controlled Clinical Intervention Study (Trial)

A Controlled Clinical Interventional Study is a multi-arm clinical interventional study that is a controlled experiment.

• AKA: Controlled Interventional Clinical Trial, Controlled Experimental Clinical Trial.
• Context:
  • It can range from being a Randomized Controlled CT to being a Non-Randomized Controlled CT.
  • It can range from being a Placebo-Controlled CT to being a Active-Treatment Controlled CT.
  • It can range from being a Phase-II Clinical Trial to being a Phase-III Clinical Trial.
  • It can range from being a Two-Arm Clinical Trial to being a Multi-Arm Clinical Trial.
  • …
• Example(s):
  • NCT02872103: Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy,
  • NCT00994110: Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess,
  • NCT00865202: A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium,
  • NCT01993823: Active Treatment-controlled Study of G238 Compared to Clotrimazole 1% Otic Solution in Patients With Otomycosis,
  • NCT01302483: Active-Treatment-Controlled Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients,
  • NCT00572156: Active-Treatment-Controlled Study of the rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency,
  • NCT00571519:Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus,
  • …
• Counter-Example(s):
  • Observational Clinical Trial,
  • Single-Arm Clinical Trial,
  • Uncontrolled Clinical Trial.
• See: Controlled Clinical Study Protocol Document, Crossover Clinical Trial, Parallel Clinical Trial, Dynamic Clinical Trial, Adaptive Clinical Trial, Clinical Trial Eligibility Criterion.

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References

2021

• https://www.bioclever.com/controlled-and-uncontrolled-clinical-trials-n-40-en
  • QUOTE: ... Controlled trials: The design of these trials includes at least one study group that is compared with a control group. The control group can receive placebo or another effective treatment. Both groups are studied simultaneously, except when historical data are used as a control. These types of trials are the most common in Phase III of drug research. Controlled trials allow the patient's outcome to be discriminated from an outcome caused by other factors, such as the natural history of the disease or the expectations of the patient or the investigator. ...

2021a

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#C Retrieved:2021-12-11.
  • Controlled clinical trial
    • A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. (NCI)
    • An experiment or clinical trial that includes a comparison (control) group. (NCI)
  • Controlled trials
    • Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo. (NLM)

2021b

• (Wikipedia, 2021) ⇒ https://www.nia.nih.gov/research/dgcg/nia-glossary-clinical-research-terms Retrieved:2021-12-11.
  • QUOTE Controlled Clinical Trial – A clinical trial in which at least one group of participants is given a test intervention, while at least one other group concurrently receives a control intervention.

2014

• (Thiese, 2014) ⇒ Matthew S. Thiese. (2014). “Observational and Interventional Study Design Types; An Overview.” In: Biochemia Medica (Zagreb). Journal, 24(2).
  • QUOTE: Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods(...)

     Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on (...)

    Epidemiological and interventional research studies include three elements; 1) definition and measure of exposure in two or more groups, 2) measure of health outcome(s) in these same groups, and 3) statistical comparison made between groups to assess potential relationships between the exposure and outcome, all of which are defined by the researcher (...). The measure of exposure in epidemiologic studies may be tobacco use (“Yes” vs. “No”) to define the two groups and may be the treatment (Active drug vs. placebo) in interventional studies. Health outcome(s) can be the development of a disease or symptom (e.g. lung cancer) or curing a disease or symptom (e.g. reduction of pain)(...)

     Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

    Interventional study designs, also called experimental study designs, are those where the researcher intervenes at some point throughout the study. The most common and strongest interventional study design is a randomized controlled trial, however, there are other interventional study designs, including pre-post study design, non-randomized controlled trials, and quasi-experiments.

2013

• (Hulley et al., 2013) ⇒ Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, and Thomas B. Newman. (2013). “Designing Clinical Research: Fourth Edition.” Wolters Kluwer Health. ISBN: 9781469840543
  • QUOTE: Clinical trial: A research design in which subjects receive one of (at least) two different interventions. Usually, the interventions are is assigned randomly; thus, the term randomized clinical trial.

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