Uncontrolled Clinical Intervention Study
An Uncontrolled Clinical Intervention Study is a clinical intervention study that is an uncontrolled clinical study (an uncontrolled experiment where participants are not assigned to specific interventions by the clinical study investigator).
- Context:
- It can range from being a Randomized Uncontrolled Clinical Trial to being a Non-Randomized Uncontrolled Clinical Trial.
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- Example(s):
- an Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP (NCT00001990) [1].
- a Phase I Clinical Trial.
- investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health. ..
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- Counter-Example(s):
- See: Treatment Group, Control Animal, Animal Preclinical Trial, Multi-Arm Clinical Trial, Dynamic Clinical Trial, Placebo-Controlled Clinical Trial, Active-Controlled Clinical Trial.
References
2021
- https://www.bioclever.com/controlled-and-uncontrolled-clinical-trials-n-40-en
- QUOTE: ... Uncontrolled trials are those that do not include a control group. A control group is made up of a group of patients that do not receive the investigational drug, but instead take the standard treatment, approved for the disease on which the study is being carried out, or takes a placebo, which is a simulation of the investigational drug, but has no activity on the studied pathology.
Uncontrolled trials are often used in the early phases of drug research, phases I and II, to determine pharmacokinetic properties or to investigate tolerated dose ranges. They can also be useful to study side effects, biochemical changes in long-term therapies, tolerance, interactions or efficacy of drugs. ...
- QUOTE: ... Uncontrolled trials are those that do not include a control group. A control group is made up of a group of patients that do not receive the investigational drug, but instead take the standard treatment, approved for the disease on which the study is being carried out, or takes a placebo, which is a simulation of the investigational drug, but has no activity on the studied pathology.
2021
- https://clinicaltrials.gov/ct2/about-studies/learn
- QUOTE: ... A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies. ...
... In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health. ..
- QUOTE: ... A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies. ...
2010
- (Sacca, 2010) ⇒ Luigi Sacca (2010). "The uncontrolled clinical trial: scientific, ethical, and practical reasons for being". Internal and emergency medicine, 5(3), 201-204.
- QUOTE: According to principles of clinical trial design, the demonstration of efficacy of a new treatment is based on comparing the response in the treated group with that of a control group receiving placebo or another active treatment. The need for a control group is also recommended by the major international institutions that govern the ethics and the practice of clinical research. Despite these principles and recommendations, inspection of a purposive sample of ongoing clinical trials listed in the NIH registry (http://ClinicalTrials.gov) reveals that as many as one-third of trials are uncontrolled. Since these trials were approved through a formal evaluation by ethics committees, the lack of adequate control was not perceived as a major deficiency in the study design. Most uncontrolled trials belong to the oncology/hematology area. If two extreme disease conditions for nature and progression are analyzed, such as acute myeloid leukemia (AML) and chronic heart failure (CHF), the difference in the prevalence of uncontrolled trials is very striking. The number of uncontrolled trials is only 13% in CHF, whereas it reaches 66% in the AML group.