Multi-Arm Interventional Clinical Study
A Multi-Arm Interventional Clinical Study is a interventional clinical trial that is a multi-arm experiment (which involves one or more experimental arms and one or more control arms).
- Context:
- It can range from being a Multi-Arm Randomized (MAR) Clinical Trial to being a Multi-Arm Multi-Stage Clinical Trial.
- It can range from being a Placebo-Controlled Multi-Arm Clinical Trial (where at least one-treatment is a placebo) to being a Active-Treatment Multi-Arm Clinical Trial.
- …
- Example(s):
- a Two-Arm Clinical Trial,
- …
- an n-Arm Clinical Trial.
- …
- Counter-Example(s):
- See: Clinical Trial Arm, Placebo Comparator Arm, Active Comparator Arm, Placebo-Controlled Clinical Trial, Active-Control Clinical Trial.
References
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: multi arm trial is a trial that has several treatment groups (arms) as well as the standard treatment group (the control group).
Multi-arm multi-stage (MAMS) trials have the same control group all the way through. But the other treatment groups can change as the trial goes on.
The research team may decide to stop recruiting people to a particular group. This could be because they have enough people to start looking at the results. Or because early results show the treatment isn’t working as well as they’d hoped.
And they may add new treatment groups as new drugs become available to look at. This means they don’t have to design and launch a brand new trial each time they want to research a new treatment. So it helps get results quicker.
The Stampede trial for prostate cancer is an example of a MAMS trial.
- QUOTE: multi arm trial is a trial that has several treatment groups (arms) as well as the standard treatment group (the control group).
2019
- (Juszczak et al., 2019) ⇒ Edmund Juszczak, Douglas G. Altman, Sally Hopewell, and Kenneth Schulz (2019)"Reporting of Multi-Arm Parallel-Group Randomized Trials. Extension of the CONSORT 2010 Statement". In: JAMA, 321(16):1610-1620. DOI:10.1001/jama.2019.3087.
- QUOTE: Multi-arm randomized clinical trials have several forms but are typically a combination of elements, including multiple active interventions, combinations of active interventions, different doses (or regimens) of an intervention, a placebo, and no active intervention, or treatment as usual. These elements can be combined in various ways resulting in numerous possible trial structures. For example, in a trial with 3 treatment groups, A1 vs A2 vs A3 could represent an evaluation of different doses of the same active intervention. Alternatively, a trial of A1 vs B1 vs C1 could represent an evaluation of 2 different active interventions and a placebo. Moreover, a study comparing A1 vs A2 vs B1 could represent an evaluation of 2 different doses of an active intervention vs another active intervention(...)
2018
- (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.
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.