The formula to calculate the Sample Size for a Clinical Trial is:
\[ n = \frac{Z^2 \cdot p \cdot (1 - p)}{E^2} \]
Where:
A clinical trial is a research study conducted to evaluate the effectiveness and safety of medical, surgical, or behavioral interventions. These trials are the primary way researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker), is safe and effective in people. Often, a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Let's assume the following values:
Using the formula:
\[ n = \frac{1.96^2 \cdot 0.5 \cdot (1 - 0.5)}{0.05^2} \approx 384.16 \]
The Sample Size is approximately 384.16.