Understanding Clinical Trials

What Are Clinical Trials?

Clinical trials are carefully designed research studies that evaluate new medical treatments, drugs, devices, or approaches to healthcare. These studies help determine if new interventions are safe and effective for human use.

Why Are Clinical Trials Important?

• Advance medical knowledge
• Develop new treatments
• Improve existing therapies
• Find better ways to prevent, detect, or treat diseases

Phases of Clinical Trials

Phase I

• Tests safety and side effects
• Small group (20-100 participants)
• First human trials after laboratory testing

Phase II

• Evaluates effectiveness
• Larger group (100-300 participants)
• Continues safety monitoring

Phase III

• Confirms effectiveness
• Large scale (300-3000 participants)
• Compares to standard treatments

Phase IV

• Post-market surveillance
• Monitors long-term effects
• Occurs after FDA approval

Participating in a Clinical Trial

Benefits

• Access to new treatments
• Close medical monitoring
• Contributing to medical advancement

Considerations

• Possible risks and side effects
• Time commitment
• Regular medical visits
• Possible placebo assignment

Patient Rights

1. Informed consent
2. Withdrawal at any time
3. Privacy protection
4. Access to study information

Finding Clinical Trials

• ClinicalTrials.gov database
• Healthcare provider referrals
• Research institutions
• Patient advocacy groups