Clinical Trial Active Comparator Arm

A Clinical Trial Active Comparator Arm is a Control Arm in which clinical trial participants receive an intervention/treatment considered to be effective.

• AKA: Clinical Trial Active Control Arm.
• Example(s):
  • In the NCT01845038:Multi-Arm Feasibility Study Evaluating OTX-TP vs Timolol in (Open Angle Glaucoma), experimental arms are OTX-TPa and OTX-TPb treatment; and active comparator arm is Timolol treatment;
  • …
• Counter-Example(s):
  • a Placebo 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: Active comparator arm: An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.

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.

2022c

• (Cancer Research UK, 2022) ⇒ https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/types-of-clinical-trials#mams Retrieved:2022-01-22.
  • QUOTE: A multi arm trial is a trial that has several treatment groups (arms) as well as the standard treatment group (the control group).

2018b

• (Ventz et al., 2018) ⇒ Steffen Ventz, Matteo Cellamare, Giovanni Parmigiani, and Lorenzo Trippa (2018). "Adding experimental arms to platform clinical trials: randomization procedures and interim analyses". In: Biostatistics, 19(2):199–215. DOI:10.1093/biostatistics/kxx030.
  • QUOTE: Multi-arm studies that test several experimental treatments against a standard of care are substantially more efficient compared to separate two-arm studies, one study for each experimental treatment. Multi-arm studies test experimental treatments against a common control arm, whereas when experimental drugs are evaluated using two-arm studies the control arm is replicated in each study. This difference reduces the overall sample size for testing multiple experimental drugs in a single multi-arm study compared to using independents two-arm trials.

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