Clinical Trial Sham Comparator Arm

A Clinical Trial Sham Comparator Arm is a Control Arm in which clinical trial participants are treatment using a medical procedure or medical device that is similar to new procedure or device but without active processes or components.

• AKA: Clinical Trial Sham Control Arm.
• Example(s):
  • NCT04889976: Portable Transcranial Electrical Stimulation and Internet-Based Behavioral Therapy for Major Depression Study (PSYLECT):
    • Experimental Arm: Active portable transcranial electrical stimulation (ptES) and active internet-based behavioral therapy (iBT),
    • Sham Comparator: Sham portable transcranial electrical stimulation (ptES) and sham internet-based behavioral therapy (iBT).
  • …
• Counter-Example(s):
  • an Active Comparator Arm,
  • a Placebo Comparator Arm,
  • a No-Intervention Arm.
• See: Medical Device Development Clinical Trial, 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: Sham comparator arm: An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components.

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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