Glossary Term
Baseline Characteristics
Definition
Baseline Characteristics refer to the demographic, clinical, and other relevant attributes of participants collected at the start of a clinical trial or study. These characteristics provide a snapshot of the study population before the intervention begins and are critical for evaluating the comparability of groups, ensuring balanced randomization, and interpreting outcomes.
Relevance to the MedTech Industry
Baseline Characteristics help MedTech companies understand the initial conditions of trial participants, ensuring the validity and reliability of study results. They allow researchers to assess whether differences in outcomes are attributable to the intervention or pre-existing factors, facilitating robust evaluations of medical devices or therapies.
Additional Information & Related Terms
Randomized Controlled Trials (RCTs) Use baseline characteristics to ensure group comparability.
Subgroup Analysis Evaluates device performance across specific baseline subgroups.
Clinical Validation Relies on baseline data to contextualize the device’s effectiveness and safety.
Post-Market Surveillance Baseline data informs ongoing evaluations of device performance in real-world use.