- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before a clinical trial starts?
- Some facts about clinical trials to keep in mind
- What are the phases of clinical trials?
- Phase 0 clinical trials: Exploring if and how a new drug may work
- Phase I clinical trials: Is the treatment safe?
- Phase II clinical trials: Does the treatment work?
- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
- Who sponsors and runs clinical trials?
- Should I think about taking part in a clinical trial?
- Answers to some common questions about clinical trials
- Other questions you should ask your research team
- How are study participants protected?
- What’s out there? Finding clinical trials
- How do I figure out which study is for me?
- What about cost? Will my insurance cover it?
- Private insurers and the new health care law
- What would it be like to be in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
- To learn more
What are the phases of clinical trials?
Clinical trials are usually conducted in phases that build on one another. Each phase is designed to answer certain questions. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied. There are pros and cons to taking part in each phase of a clinical trial.
Although there are clinical trials for devices as well as other diseases and treatments, drugs for cancer patients are used in the examples of clinical trial phases described here.
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014