- 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
Should I think about taking part in a clinical trial?
This is one of the toughest questions many people with cancer will face. The answer won’t be the same for everyone. When trying to decide, first ask yourself some basic questions:
- Why do I want to take part in a clinical trial?
- What are my goals and expectations if I decide to take part? How realistic are these?
- How sure are my doctors about what my future holds if:
- I decide to participate?
- I decide not to participate?
- Have I considered the chance of benefits versus the risks
- Have I considered other possible factors, such as travel, time, and money?
- Have I considered my other possible options?
Some of these questions may not have clear-cut answers, but they should help you start thinking about some important issues. Each person’s situation is unique, and each person’s reasons for wanting or not wanting to take part in a study may be different.
Risk versus benefit
Each clinical trial offers its own opportunities and risks, but most have some things in common. For the most part, clinical trials (other than phase 0) have some of the same potential benefits:
- You might help others who have the same condition in the future by helping to advance cancer research.
- You could have access to treatment that’s not otherwise available, which might be safer or work better than current treatment options.
- You may increase the total number of treatment options available to you, even if you haven’t yet had all of the standard treatments.
- You may feel you have more control over your situation and are taking a more active role in your health care.
- You’ll probably get more attention from your health care team and more careful monitoring of your condition and the possible side effects of treatment if you take part in a clinical trial.
- Some study sponsors may pay for part or all of your medical care and other expenses during the study. (This isn’t true for all clinical trials. Be sure you know who’s expected to pay for your care before you enroll in the study.)
Some of the possible downsides of being in a study can include:
- The new treatment may have unknown side effects or other risks, which may or may not be worse than those from existing treatments. This is especially true of early phase trials.
- As with other forms of therapy, the new treatment may not work for you even if it helps others.
- There may be inconveniences such as more frequent office visits and testing, as well as time and travel commitments.
- If you take part in a randomized clinical trial, you may not have a choice about which treatment you get. If the study is blinded, you (and maybe your doctor) will not know which treatment you’re getting (although this information is available if needed for your safety). This will be explained to you before you decide to take part.
- Insurers may not cover all of the costs of taking part in a clinical trial, but they usually cover the costs of what would normally be standard care. Be sure to talk to your insurance provider and to someone involved with the study before you decide to take part, so you know what you may have to pay for. (There’s more on this in the section called “What about cost? Will my insurance cover it?”)
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014