Kidney Disease Research

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:

Phase 1

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.

Phase 2

Tests for safety and effectiveness in a larger group (100-300).

Phase 3

Given to large groups (1,000-3,000) to test for effectiveness and side effects, and compare with standard or common treatments.

Phase 4

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.

Where Can You Find Trials?