Fully-Randomized Controlled Experiment

A Fully-Randomized Controlled Experiment is a randomized controlled experiment that is a subject-level assignment experiment.

• Context:
  • It can be analyzed by a Subject-level Randomized Experiment Analysis.
  • It can range from being a Crossover Subject-level Randomized Experiment to being a One-Shot Subject-level Randomized Experiment.
  • It can range from being a One-Factor Subject-level Randomized Experiment to being a Two-Factor Subject-level Randomized Experiment to being a Many-Factor Subject-level Randomized Experiment.
  • It can be Subject-level Placebo-Treatment Randomized Experiment.
  • It can range from being a Therapeutic Treatment Subject-level Randomized Experiment to being a Preventative Treatment Subject-level Randomized Experiment.
  • …
• Counter-Example(s):
  • a Cluster Randomized Controlled Experiment.
• See: Case-Control Study, Bivariate (A/B) Controlled-Experiment Test.

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References

2013

• (Wikipedia, 2013) ⇒ http://en.wikipedia.org/wiki/Randomized_controlled_trial
  • QUOTE: A randomized controlled trial (RCT) (or randomized control trial or randomized comparative trial) is a specific type of scientific experiment, and the gold standard for a clinical trial. RCT are often used to test the efficacy and/or effectiveness of various types of medical intervention within a patient population. RCT may also provide an opportunity to gather useful information about adverse effects, such as drug reactions.

    The key distinguishing feature of the usual RCT is that study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation in real trials is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, follow-up calls etc. should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments."

    The terms "RCT" and randomized trial are often used synonymously, but some authors distinguish between "RCTs" which compare treatment groups with control groups not receiving treatment (as in a placebo-controlled study), and "randomized trials" which can compare multiple treatment groups with each other. RCTs are sometimes known as randomized control trials. RCTs are also called randomized clinical trials or randomized controlled clinical trials when they concern clinical research; however, RCTs are also employed in other research areas, including many of the [[#Randomized controlled trials in the social sciences|social science]]s, where their relevance and the advantages claimed for them have been contested in the literature.^{[citation needed]}

• http://en.wikipedia.org/wiki/Randomized_controlled_trial#By_study_design
  • One way to classify RCTs is by study design. From most to least common in the medical literature, the major categories of RCT study designs are: …

    … An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.

2010

• (AMTA, 2010) ⇒ American Massage Theory Association. (2010). “Glossary of Research Terminology."
  • QUOTE: Randomized Controlled Trial (or True Experimental) Research Method: One of four research methods included under the difference-oriented research strategy. It is operationally defined as a research method necessitating two major research procedures/features]]: (a) the random assignment of participants to the two or more comparison groups (i.e., the levels of the independent variable) and (b) the use of a manipulated independent variable as the study’s treatment or intervention. (Please note that the term controlled in the expression randomized controlled trial designates that the group being compared to the experimental group is a no treatment or “do nothing” control group or, possibly, a waiting-list control group. As suggested by Hagino (2003), the expression randomized clinical trial is preferred when the comparison to the experimental group involves a comparison treatment control group as is the case with a standard treatment control group, placebo-attention control group, or placebo-sham treatment control group.)

2008

• http://www.drcath.net/toolkit/intervention.html
  • The randomised controlled trial is considered to be the gold standard of clinical research because it is the only known way to avoid selection and confounding biases. It approximates the controlled experiment of basic science. The aim of a trial is to apply the conclusions of the experiment to people in the general population.

    An important feature of Randomised Controlled Trials is randomisation. Here, participants (volunteers) are assigned to exposures purely by the play of chance. This reduces the likelihood of bias in the determination of outcomes and precludes selction bias and confounding bias. If participants and researchers are blinded as to the exposure the participant is receiving (called 'double-blinding'), information bias is also reduced. Allocation of people to treatment and control groups can be done by simple randomisation, randomsiation in blocks, randomisation by strata or minimisation. Minimisation is an acceptable non-random method of group allocation in trials. It considers people who are already allocated and allocates the next patient in such a way as to keep the composition of the two groups as similar as possible with respect to certain specified factors.

2007

• (Parienti & Kuss, 2007) ⇒ Jean-Jacques Parienti, and Oliver Kuss. (2007). “Cluster-Crossover Design: A method for limiting clusters level effect in community-intervention studies.” In: Contemporary Clinical Trials, 28(3). doi:10.1016/j.cct.2006.10.004
  • QUOTE: The number of cluster-periods increases as the number of randomizations per cluster increases and the periods become shorter. A “pure” individual-randomized controlled trial can be considered as a particular case of cluster-crossover, with a new randomization for every new statistical unit.

2000

• (Concato et al., 2000) ⇒ John Concato, Nirav Shah, and Ralph I. Horwitz. (2000). “Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs.” In: N Engl J Med, 342(25). PMCID: PMC1557642

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