Mega-trial
- A clinical trial enrolling a very large number of participants to increase statistical power.
- Designed to detect even small differences between treatment and control groups.
- Commonly used to evaluate treatments for widespread conditions (for example, heart disease and diabetes).
Definition
Section titled “Definition”A mega-trial, also known as a large simple trial, is a type of clinical trial that involves a very large number of participants. These trials are often conducted to evaluate the effectiveness of a particular treatment or intervention, and they are typically designed to provide a high level of statistical power, which means that they are able to detect even small differences between the treatment and control groups.
Explanation
Section titled “Explanation”Mega-trials enroll substantially larger participant samples than typical clinical trials to improve the ability to identify modest treatment effects. Their large scale and simplified designs focus on measuring clinically meaningful outcomes across broad populations, which supports robust evaluation of treatments or interventions and yields high-quality evidence to inform clinical practice and decision-making.
Examples
Section titled “Examples”Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial
Section titled “Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial”This trial involved over 2,300 participants and was designed to evaluate the effectiveness of revascularization (a surgical procedure that improves blood flow to the heart) in combination with aggressive medical therapy (such as the use of drugs to control cholesterol and blood pressure) in patients with chronic stable angina. The results of the COURAGE trial showed that revascularization did not provide any additional benefit to patients when compared to aggressive medical therapy alone.
Diabetes Prevention Program (DPP) trial
Section titled “Diabetes Prevention Program (DPP) trial”This trial involved over 3,000 participants and was designed to evaluate the effectiveness of lifestyle interventions (such as diet and exercise) in preventing the development of type 2 diabetes in individuals who were at high risk for the disease. The results of the DPP trial showed that lifestyle interventions were effective at reducing the incidence of type 2 diabetes by 58% compared to placebo.
Use cases
Section titled “Use cases”Mega-trials are used to provide high-quality evidence about the effectiveness of treatments and interventions, often for common conditions such as heart disease and diabetes, and to help guide clinical practice and inform decision-making.
Related terms
Section titled “Related terms”- Large simple trial
- Clinical trial