Glossary Term
Control Group
Definition
A Control Group in clinical research is a group of participants that does not receive the experimental treatment or device under study. Instead, they may receive a standard treatment, placebo, or no intervention at all. The control group serves as a baseline for comparison, allowing researchers to assess the efficacy and safety of the investigational product.
Relevance to the MedTech Industry
The control group is essential for generating reliable and unbiased data in clinical trials. By providing a standard for comparison, it helps to isolate the effects of the investigational product and ensures that observed outcomes are attributable to the treatment or device being studied.
Additional Information & Related Terms
Randomized Controlled Trials (RCTs) The gold standard study design that typically incorporates control groups.
Comparator Group Includes control groups but may also compare the investigational device to a standard treatment or another product.
Clinical Trial Design Defines how control groups are used to evaluate outcomes effectively.
Blinding/Masking Used to reduce bias in studies involving control groups.