- 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
Clinical Trials: What You Need to Know
Clinical trials are studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe for people. These kinds of studies are needed to develop new treatments for serious diseases such as cancer.
A clinical trial could be an option for you. If you meet the requirements for one, you will get to decide if you want to take part in it.
Parents or guardians decide if they will permit their child to take part in a clinical trial. If the parents give permission, older children are usually asked whether they wish to take part. In most cases, a child can refuse, even if the parents are willing to permit it. Otherwise, the process of considering a clinical trial is similar for the parents of a child as it is for an adult, so the process for children is not addressed separately here.
There’s always uncertainty when you’re thinking about a clinical trial. Part of it is that the doctors in charge of a clinical trial don’t know ahead of time how things will turn out. If they did, there would be no need for the study in the first place. So there’s no simple answer to the question, “Should I take part in a clinical trial?”
Most people don’t pay much attention to clinical trials until they have a serious illness. Medical breakthroughs (the results of clinical trials or other kinds of research) often make the news, but you usually don’t hear about clinical trials themselves unless something has gone wrong in one of them. For instance, the media quickly reports it any time a volunteer in a study is harmed. Although it’s very rare, people have been harmed or even died while taking part in clinical trials. Reports of these tragic outcomes are important, because they help to expose problems in the system. These problems can then be handled so that they don’t happen again. And there are now many laws, requirements, and procedures in place to protect the rights and the health of human volunteers.
What you usually don’t hear about in the news are the thousands of people who are helped each year because they decided to take part in a clinical trial. You also aren’t likely to hear about the millions who benefit from others’ participation in clinical trials.
There’s no right or wrong choice when it comes time to decide on taking part in a clinical trial. The decision is a very personal one and depends on many factors, including the benefits and risks of the study and what you hope to achieve by taking part. It also depends on your own values, preferences, and priorities.
Knowing all you can about clinical trials in general – as well as the ones you’re thinking about taking part in – can help you feel better about your decision. If you do decide to take part, knowing what to look for and what to expect ahead of time can be helpful, too.
Here we will address many basic questions and concerns so you’ll be better prepared to discuss clinical trials with your doctor and your family. We’ll try to help you decide which questions you need to ask and what the answers may mean for you. But in the end, only you can decide if taking part in a clinical trial is right for you.
One last note: We focus on clinical trials for people who are being treated for cancer. But most of the information here applies to other types of clinical trials, too.
Last Medical Review: 09/25/2014
Last Revised: 10/31/2014