Clinical Trial Control Arm
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A Clinical Trial Control Arm is a Clinical Trial Arm that corresponds to a control group in which clinical trial participants receive a standard health care that can be used as a reference and compared against a experimental treatment.
- AKA: Clinical Trial Comparator Arm.
- Context:
- It can be a control group in which clinical trial participants receiving inactive or active treatment/intervention with known clinical response and outcome.
- It can be a control group in which clinical trial participants being treated with a already studied, approved, marketed medical device.
- Example(s):
- Counter-Example(s):
- See: Single-Arm Clinical Trial, Multi-Arm Clinical Trial, Placebo-Controlled Clinical Trial, Exploratory Clinical Trial, Confirmatory Clinical Trial, Control Group, Placebo Group, Biological Comparator System, ** Comparator Hypothesis, Crossover Clinical Trial.
References
2022
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2022-01-22.
- QUOTE: Comparator
- An investigational or marketed product (i.e., active control), or placebo, . (ICH E6)
- QUOTE: Comparator
2022
- (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).
2018a
- (Pallmann et al., 2018) ⇒ Philip Pallmann, Alun W. Bedding, Babak Choodari-Oskooei, Munyaradzi Dimairo, Laura Flight, Lisa V. Hampson, Jane Holmes, Adrian P. Mander, Lang’o Odondi, Matthew R. Sydes, Sofia S. Villar, James M. S. Wason, Christopher J. Weir, Graham M. Wheeler, Christina Yap, and Thomas Jaki (2018)."Adaptive designs in clinical trials: why use them, and how to run and report them". In: BMC Medicine, 16(29).
- QUOTE: Telmisartan and Insulin Resistance in HIV (TAILoR) was a phase II dose-ranging multi-centre randomised open-label trial investigating the potential of telmisartan to reduce insulin resistance in HIV patients on combination antiretroviral therapy [1]. It used a MAMS design[2] with one interim analysis to assess the activity of three telmisartan doses (20, 40 or 80 mg daily) against control, with equal randomisation between the three active dose arms and the control arm.
- ↑ Pushpakom SP, Taylor C, Kolamunnage-Dona R, Spowart C, Vora J, García-Fiñana M, et al. Telmisartan and insulin resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy. BMJ Open. 2015; 5:e009566.
- ↑ Magirr D, Jaki T, Whitehead J. A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection. Biometrika. 2012; 99:494–501.
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.
2015
- (Cohen et al., 2015) ⇒ Dena R. Cohen, Susan Todd, Walter M. Gregory, and Julia M. Brown (2015). "Adding a treatment arm to an ongoing clinical trial: a review of methodology and practice.". In: Trials, 16(179).
- QUOTE: This review investigates the addition of a new treatment arm to an ongoing trial within the following scope: the trial has already begun recruitment and the randomisation is still open when the new treatment is added, the trial has a confirmatory primary objective, the trial is designed using frequentist methodology (due to the differences in assumptions and considerations with Bayesian methodology), and the entire treatment arm is new rather than an amendment to an existing arm.
2010
- (Evans, 2010) ⇒ Scott R. Evans (2010). "Clinical trial structures". In: Journal of experimental stroke & translational medicine, 3(1), 8.
- QUOTE: The simplest trial design is a single-arm trial. In this design, a sample of individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response. This design is employed when the objective of the trial is to obtain preliminary evidence of the efficacy of the treatment and to collect additional safety data, but is not generally used as confirmation of efficacy. The design may be desirable when the available patient pool is limited and thus it is not optimal to randomize many participants to a control arm.