Glossary Term
Secondary Outcome Measure
Definition
A secondary outcome measure is a secondary, but still important, variable used in clinical trials to assess additional effects or benefits of a treatment, intervention, or medical device beyond the primary outcome measure. Secondary outcome measures are typically used to evaluate other aspects of effectiveness, safety, or patient well-being, and may provide further insights into how the device or treatment impacts the patient or population. Unlike primary outcome measures, which are the main focus of the study, secondary outcome measures offer supplementary data that can help deepen the understanding of a product's performance.
Relevance to the MedTech Industry
Secondary outcome measures provide a broader picture of the impact a treatment or device can make by evaluating other relevant health aspects, such as quality of life, secondary health conditions, adverse events, or long-term benefits. These measures offer additional evidence that can support regulatory submissions, reimbursement decisions, and clinical use, helping stakeholders assess the overall value and safety of a product
Additional Information & Related Terms
Examples of Secondary Outcome Measures
Medical Device Performance Evaluation:
In a clinical trial for a new stent, secondary outcome measures might include the incidence of complications like restenosis, stroke, or bleeding, in addition to the primary outcome of stent patency.
Example: A company conducts a clinical trial for a new heart stent, tracking secondary outcomes like patient mobility, the need for follow-up procedures, and long-term health impacts.
Effectiveness of a Pharmaceutical Treatment:
A pharmaceutical trial might include secondary outcomes like quality of life improvements or reductions in side effects to complement the primary outcome of symptom relief.
Example: A clinical trial for a new migraine drug assesses secondary outcomes, such as a decrease in the frequency of migraine attacks and improvements in sleep quality.
Surgical Device Impact on Recovery:
A trial for a new surgical tool may include secondary outcomes such as recovery time, post-operative pain, and complications, in addition to the primary outcome of successful surgery rates.
Example: A company develops a new surgical stapler and includes secondary outcomes like reduced blood loss, shorter recovery times, and fewer complications in their clinical trial.
Related Terms
Primary Outcome Measure: The main variable or outcome the study is designed to assess, usually representing the primary hypothesis of the clinical trial.
Clinical Trial Design: The process of planning and structuring a clinical trial, which includes identifying primary and secondary outcome measures to assess the intervention’s effects.
Endpoint: A predefined outcome or event used to measure the effectiveness of a treatment in clinical trials.
Patient-Reported Outcome (PRO): An outcome measure based on the patient’s personal assessment of their health status, such as quality of life, pain levels, and physical function.
Multivariate Analysis: A statistical method used to analyze multiple outcomes or variables simultaneously, often used when evaluating secondary outcomes in clinical trials.