- 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
Other questions you should ask your research team
Each clinical trial is unique, with its own possible benefits and risks. Before you decide to take part in one, you may want answers to these questions. Some people take notes, record discussions, or bring a friend with them to help recall the answers and think of other questions:
- Why is this study being done?
- What’s likely to happen if I decide to take part or decide not to take part in the study?
- What are my other options (standard treatments, other studies)? What are their pros and cons?
- How much experience do you have with this particular treatment? With clinical trials in general?
- What were the results in earlier studies of this treatment? How likely are they to apply to me?
- What kinds of treatments and tests would I need to have in this study? How often are they done?
- Will this require extra time or travel on my part?
- How could the study treatment affect my daily life?
- What side effects might I expect from the study treatment? Are there other risks? (Keep in mind that there can also be side effects from standard treatments and from the disease itself.)
- How will we know if the treatment is working?
- Will I have to be in the hospital for any parts of the study? If so, how often, for how long, and who will pay for it?
- Will I still be seeing my regular doctor? Who will be in charge of my care during the study?
- Will I have any costs? Will any of the treatment be free? Will my insurance cover the rest?
- If I am harmed as a result of the research, what treatment will I be entitled to?
- How long will I be in the study? How long will the study last?
- Are there reasons I would be removed from the study? Are there reasons the study might be stopped early?
- Is long-term follow-up care part of the study? What would it involve?
- If the treatment is working for me, can I keep getting it even after the study ends?
- Can I talk to other patients already taking part in the study?
- Will I be able to find out about the results of the study?
You might find it helpful to include trusted friends and family members in your decision making process. They might ask questions you hadn’t thought of and can help you make sure that you’re making a decision that’s right for you. Also, getting a second opinion from a doctor who’s not involved with the study can give you a broader sense of whether a certain study is the best one for you.
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014