Glossary Term
Arm (in Clinical Trials)
Definition
An Arm in clinical trials refers to a group or subset of participants assigned to receive a specific intervention, treatment, or placebo. Each arm represents a distinct pathway or treatment regimen being studied, allowing researchers to compare outcomes across different groups to evaluate the safety and efficacy of the interventions.
Relevance to the MedTech Industry
In the MedTech industry, defining arms in clinical trials is critical for assessing the performance of medical devices under controlled conditions. This segmentation enables rigorous comparisons between different treatment options, device configurations, or placebo controls, generating evidence for regulatory submissions and clinical decision-making.
Additional Information & Related Terms
Randomized Controlled Trials (RCTs) Clinical trials with participants randomly assigned to different arms.
Blinding/Masking Ensures participants and investigators are unaware of arm assignments to reduce bias.
Placebo-Controlled Study An arm in the trial receives a placebo for comparison against the active intervention.
Clinical Validation Uses data from trial arms to confirm device safety and efficacy.