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The basics of clinical trials

Doctors, including many of those at Gundersen Health System, use clinical trials to learn whether a new treatment works and provides a better outcome than the standard treatment being offered. These kinds of studies are needed to develop new treatments for serious diseases like cancer.

Clinical trials are vital in studying all aspects of medicine, not just cancer. The stakes may seem higher when researching medicines to treat cancer, but all new treatments (drugs and medical devices) must go through clinical trials before being approved by the FDA.

At any given time, there are more than 100 clinical trials available at Gundersen.

Who can be in clinical trials?

Participation in a clinical trial can benefit many cancer patients. People of all ages can take part in clinical trials. If you find a clinical trial that interests you, there are formal steps that must be taken to join the study.

For a child to be enrolled in a clinical trial, the parents or guardians must decide if they want their child to take part. If the parents give permission, older children are usually asked whether they wish to take part. This process is called assent. In most cases, a child can refuse, even if the parents are willing to permit it. The process of considering a clinical trial is much the same for the parents of a child as it is for an adult.

There may be some uncertainty when you're thinking about a clinical trial. While it is true that your doctor will not know for sure how a particular clinical trial may work for you, there are specific criteria a patient has to meet in order to participate. Trials offered at Gundersen have often gone through the initial phase of study, which reduces the risk of the trial not working or being potentially harmful but does not entirely eliminate the risk.

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 that lead to the breakthroughs. The truth of the matter is that thousands of people are helped each year because they decided to take part in a clinical trial. Because of their participation, millions of others also benefit.

New treatments have to pass many tests before they get to you

Clinical trials are only a small part of the research that goes into developing a new treatment. Drugs of the future, for example, first have to be discovered or created, purified, described and tested in labs (in cell and animal studies) before ever reaching human clinical trials. Of all the substances that are tested in these early stages, very few are promising enough to be tested in humans.

On average, a new cancer drug has been studied for at least six years before it even makes it to clinical trials. But the major holdup in making new cancer drugs available is how long it takes to complete clinical trials themselves. It takes an average of about eight years from the time a cancer drug enters clinical trials until it's approved.

Who sponsors and runs clinical trials?

With support from Gundersen Medical Foundation, the Cancer and Blood Disorders Center at Gundersen offers research studies through participation in regional and national cancer treatment cooperative groups.

One of these groups is the National Cancer Institute (NCI), which sponsors (pays for) a good portion of the thousands of cancer clinical trials going on in the United States at any given 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 through the NCI's National Clinical Trials Network (NCTN), 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, often sponsor cancer clinical trials. And, there are doctors, academic medical centers, foundations, volunteer groups and other nonprofit 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.

Community hospitals across the country, such as Gundersen, also take part in clinical trials. Many of these hospitals are part of the NCI's Community Oncology Research Program (NCORP), which means they work with an NCI cancer center or the National Clinical Trials Network. NCORP members conduct the same clinical trials across the country. Community hospitals may conduct privately sponsored and other types of studies, too.

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