Clinical Research Trials: What, How, and Why?
A clinical trial is a study to test a treatment in one or more humans. Those who take part may be randomly assigned to the treatment—or to a control (e.g., a placebo or other treatment). Clinical trials have four phases:
Tests for safety and side effects in a small group (20-80). Phase 1 trials are the most risky, because the least is known about how the treatment will affect humans.
Tests for safety and effectiveness in a larger group (100-300).
Given to large groups (1,000-3,000) to test for effectiveness and side effects, and compare with standard or common treatments.
After-market safety, risk/benefit, and optimal use testing.
What’s in it for you?
- You can try a new treatment early.
- You can help your fellow patients and improve how a health problem is treated in the future.
- You can get care from a leading health center and meet experts who know about your health problem.
- You can learn about other treatments that are in use now.
What are the risks?
- A new treatment may have harmful—or even lethal—side effects.
- It may take a lot of time to travel to and from the study site.
- Health insurance may not cover all of the study costs.