Clinical Trial Guide
Everything you need to know about participating in clinical research.
In This Guide
1. What Are Clinical Trials?
Clinical trials are research studies that test how well new medical approaches work in people. They are the final step in a long process that begins with research in a lab. Many treatments used today are the result of past clinical trials.
Trials may study new drugs, devices, procedures, or ways to use existing treatments. They are designed to answer specific research questions and find better ways to prevent, screen for, diagnose, or treat diseases.
2. The Four Phases
Phase 1: Safety
Small groups (20-100 people) receive the treatment for the first time. Researchers evaluate safety, determine safe dosage ranges, and identify side effects.
Phase 2: Effectiveness
Larger groups (100-300 people) receive the treatment to see if it is effective and to further evaluate safety.
Phase 3: Comparison
Large groups (1,000-3,000+ people) receive the treatment to confirm effectiveness, monitor side effects, and compare to standard treatments.
Phase 4: Post-Marketing
After FDA approval, ongoing studies track long-term effects and optimal use in the general population.
3. Benefits and Risks
Potential Benefits
- • Access to new treatments before widely available
- • Close monitoring by a research team
- • Help others by contributing to research
- • Possible compensation for time and travel
- • Free study-related medical care
Potential Risks
- • Unknown side effects
- • Treatment may not work for you
- • May receive placebo in some studies
- • More visits than regular care
- • Time commitment required
4. Eligibility Criteria
Each trial has specific eligibility criteria—requirements that must be met to participate. These criteria help ensure participant safety and that the study will produce meaningful results.
Common criteria include:
- Age range (e.g., 18-65 years old)
- Specific diagnosis or condition
- Stage or severity of disease
- Previous treatments tried
- Overall health status
- Geographic location
5. What to Expect
Screening
Initial tests and evaluations to confirm eligibility.
Informed Consent
Detailed explanation of the study, risks, and your rights before you agree to participate.
Treatment Period
Receiving the study treatment according to the protocol, with regular visits for monitoring.
Follow-Up
Continued monitoring after treatment to track long-term effects.
6. Your Rights
As a clinical trial participant, you have important rights that are protected by law:
- Voluntary participation — You can choose not to participate or withdraw at any time.
- Informed consent — You must be fully informed about the study before agreeing.
- Privacy protection — Your personal information is protected by law.
- Access to results — You can request information about study findings.
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