A clinical trial is a structured, prospective research study conducted on human participants to evaluate the safety, efficacy, or optimal use of a medical intervention—such as a drug, device, surgical technique, or diagnostic method.

Clinical trials are typically conducted in phases:

• Phase I – Assesses safety and dosage in a small group of healthy volunteers or patients.
• Phase II – Evaluates preliminary efficacy and side effects in a larger patient group.
• Phase III – Confirms efficacy and monitors adverse reactions in large populations across multiple centers.
• Phase IV – Post-marketing surveillance to gather long-term safety and effectiveness data.

In neurosurgery, clinical trials are crucial for validating innovations like new implantable devices, surgical techniques, or technologies such as 3D virtual reality and robotic-assisted surgery.

A properly designed clinical trial includes:

• Defined inclusion and exclusion criteria
• Randomization and control groups
• Blinding (where possible)
• Statistically powered sample size
• Pre-registered outcomes and ethical approval

Clinical trials are a cornerstone of robust evidence and are essential for integrating new interventions into standard practice.