- 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 if I’m not eligible for a clinical trial?
Some people may be too sick or have other problems that keep them from taking part in clinical trials, but most people will probably be eligible for some type of study. This is true even if they’ve had many different treatments already. Of course, not all studies you are eligible for are a good fit for you. It’s always important to understand the purpose of the study and have a good idea of the possible risks and benefits for you.
Some people may be interested in a certain treatment that’s only available in clinical trials, but they don’t meet the eligibility criteria outlined for the studies. In some of these cases, a person’s doctor may ask the study sponsor if they can get an eligibility waiver or special exception to allow the person into the study, even though they don’t meet all of the criteria. This decision is usually made by the study’s clinical investigator, who may consult with others involved in the study about the request. If entered in the study, the person is treated according to the study protocol (the same tests, doctor’s visits, follow-up, etc.), but the results from that person are not included in the final study results.
In other cases, the studies may have already enrolled enough people and aren’t taking any more participants.
At times, there may be ways to get access to treatments that are in late phase clinical trials but not yet approved by the FDA. These are usually referred to as expanded access or compassionate use programs. In recent years the FDA has broadened these programs to allow some patients who urgently need these treatments to be able to get them. For more, see our document called Compassionate Drug Use.
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014