Clinical Trial Placebo Comparator Arm

A Clinical Trial Placebo Comparator Arm is a Control Arm in which clinical trial participants receive a placebo.

• AKA: Clinical Trial Placebo Control Arm.
• Example(s):
  • NCT04468087: Antiviral Agents Against COVID-19 Infection (REVOLUTIOn):
    • Experimental Arm: Atazanavir, Daclatasvir 60 mg, Sofusbuvir + Daclatasvir 60 mg
    • Placebo Comparator: Placebo Atazanavir, Placebo Daclatasvir, Placebo Sofusbuvir + Daclatasvir
  • …
• Counter-Example(s):
  • an Active Comparator Arm,
  • a Sham Comparator Arm,
  • a No-Intervention Arm.
• See: Single-Arm Clinical Trial, Multi-Arm Clinical Trial, Placebo-Controlled Clinical Trial, Exploratory Clinical Trial, Confirmatory Clinical Trial, Parallel Clinical Trial, Crossover Clinical Trial.

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References

2022a

• (ClinicalTrials.gov, 2022) ⇒ https://www.clinicaltrials.gov/ct2/about-studies/glossary Retrieved:2022-01-22.
  • QUOTE: Placebo comparator arm: An arm type in which a group of participants receives a placebo during a clinical trial.

2022b

• (FOCR, 2022) ⇒ https://friendsofcancerresearch.org/randomized-and-single-arm-trials Retrieved:2022-01-22.
  • QUOTE: An arm of a clinical trial is a group of patients receiving a specific treatment (or no treatment). Trials involving several arms, or randomized trials, treat randomly-selected groups of patients with different therapies in order to compare their medical outcomes. Experimental arms, which receive an experimental drug, are compared with control arms, which can receive an active comparator (another therapy used to treat the same condition as the experimental therapy), a placebo comparator (an inactive therapy), a sham comparator (an inactive therapy made to look identical to the active therapy), or no intervention. Some clinical trial designs, such as the lung cancer master protocol design, allow for several experimental drugs to be tested simultaneously.

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