- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before clinical trials?
- Some facts about clinical trials: Important points 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
- What protects the study participants?
- 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?
- What would it be like to take part in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
Who sponsors and runs clinical trials?
The National Cancer Institute (NCI) sponsors (pays for) a good portion of the thousands of cancer clinical trials going on at any one time. The NCI is a part of the National Institutes of Health (NIH), which is funded by US tax dollars. These studies are often run by NCI-sponsored cancer cooperative groups, which are networks of doctors and institutions across the country that specialize in a certain aspect of cancer.
NCI Cancer Centers also conduct research at their facilities across the United States. Government agencies other than NCI, including parts of the Department of Veterans Affairs and the Department of Defense, sponsor cancer clinical trials. And, there are doctors, academic medical centers, foundations, volunteer groups, and other non-profit organizations that sponsor clinical trials, too.
The other main sponsors of clinical trials are pharmaceutical and biotechnology companies, which must prove their medicines or devices are safe and effective before they can be marketed.
Researchers conduct clinical trials in many different settings. Major cancer centers are often the focal points of clinical trials research. Because they usually have the most advanced facilities and highly trained staffs, they can conduct all phases of clinical trials. (See National Cancer Institute Cancer Center Programs to learn more about this.) But they are not the only places where these studies take place.
Community hospitals across the country also take part in clinical trials, although these are usually phase II or III studies. Many of these hospitals are part of the NCI’s Community Clinical Oncology Program (CCOP), which work with an NCI cancer center or clinical trials cooperative group. CCOP members conduct the same clinical trials across the country. Community hospitals may conduct privately sponsored and other types of studies, too. The NCI Community Cancer Centers Program is also testing the idea of putting cancer research in home communities, so that people don’t have to travel far to be in clinical trials.
Doctors in private practice can also be involved in clinical trials, either as members of cooperative groups or by being actively involved in privately sponsored research.
What this may mean for you
At one time, clinical trials were done only at major medical centers. This often meant that patients had to travel long distances and were treated by doctors they didn’t know very well. This is sometimes still the case, especially with phase I and some phase II studies. Of course, this is not always a bad thing. Many people prefer to be treated in major cancer centers because of their experience, reputation, and resources. Ultimately, the hassles of traveling must be weighed against the chance of being helped by the treatment.
Today, patients have more options. This may include staying closer to home during a study or even staying with their own doctors. Your doctor may or may not be involved in clinical trials. If he or she is, you may be eligible for one of them. Whether this is the right study for you is, of course, a question worth asking. Keep in mind, each study also has its own requirements that a person must meet to take part. See “Eligibility (inclusion) criteria” in the section called “How do I figure out which study is for me?” to learn more about this.
Although clinical trials are now done in many different settings, the same rules are in place to protect patients.
Having so many options can be a burden in and of itself. With the thousands of clinical trials taking place across the country, how can you – or even your doctor – decide which one is best for you? At this time, there is no complete list of all the cancer clinical trials. But there are some good places to start looking if you’re interested. We’ll explore these in the section, “What’s out there? Finding clinical trials.”
Last Medical Review: 09/21/2012
Last Revised: 09/21/2012