What is a clinical study?

A clinical study (also called a clinical trial) is a research study that tries to find a better
treatment for cancer. In a randomized clinical study, one or more types of treatment are being compared to the standard treatment (the current way patients are treated for their cancer).

What is randomization?

In Phase 2 and Phase 3 clinical studies, patients are randomized (or randomly assigned) to different groups that receive different treatments. Randomization is a method used to ensure the research study is fair. It means that patients are assigned by chance to different treatment groups.

Some people have found it helpful to view randomization to groups like the “sex of a baby”. A pregnant woman has an equal chance of giving birth to a male or female just like a patient has an equal chance of being assigned to a treatment group.

Are clinical studies for people who have no other treatment options?

Not always. There certainly are some situations where research studies will involve new treatments that are not used for that particular cancer and a patient might want to consider that as an option and a physician might want to consider offering that as an option when there are no other good options available. However, the vast majority of research otherwise involves making what we currently know to be the best treatments available better, with less side effects or shorter in duration or to otherwise optimize and improve patients’ chances to be rid of the cancer or living longer and better as a result of the treatments. So they’re not always involving just a last resort.

 Why should I participate?

Your health care provider will talk to you about the opportunity to be in a clinical study;
however, it is your choice. If you decide to be in a research study, you are able to leave
the study at any time. This decision will not harm your relationship with your health care
team in any way

What are the risks/benefits associated with the study?

Just like with standardized treatments, clinical studies have risks and benefits associated with participating.

Benefits

  • Help others by contributing to medical research
  • Take charge on his/her own health care
  • Have constant access to doctors and other medical professionals who are designated to working specifically with your loved one’s health
  • Having certain costs, including medical care and tests, covered by sponsor

Risks

  • Side effects may be more harmful than expected
  • Treatment may not be more effective than traditional options
  • There is a chance the treatment may not work at all
  • Chance of minor discomfort throughout study
  • Detailed list of risks should be included in informed consent section

Is it dangerous to be in a clinical study?

Experimental treatments do have side effects, and some of them can be unpleasant or even dangerous. But conventional treatments can have dangerous side effects, too. Patients enrolled in clinical studies are monitored closely by doctors and research nurses, who watch for early signs of complications and side effects and can stop the treatment immediately if problems develop. Plus, every clinical study must be approved by an Institutional Review Board or IRB. IRBs include physicians, scientists and community members who review every study in advance to ensure that the benefits to study participants outweigh any risks involved in being part of the study.

Are all clinical studies the same?

They are not the same, and each has different risk levels. The study could be testing a new drug that doesn’t have much information, or an old drug that has a new use. It depends on the question the investigator is trying to answer and what information is already out there. Sometimes the discovery is made just by reviewing a patient’s chart, but the patient will still need to give consent to do that so they will still be participating in the study.

Can I speak to someone who has had my diagnosis and participated in a clinical study?

Ask your healthcare provider or your nurse and they can try and make that connection for you.

There is so much information. How do I sort it all out?

A clinical study can be overwhelming at first. Try to find a family member or a friend that can help you go through the information thoroughly. Some individuals prefer recruiting a family member or friend with medical experience, although that is not necessary. A second pair of eyes from someone you trust will be helpful in sorting through the information.

What other options are available?

Clinical studies may not always be the second option. In fact, even healthy participants may decide to participate. However, they are an alternative to standardized treatment, which is the traditional and widely used format.

How much will it cost?

Before you decide on whether or not to participate in a clinical study, be sure and ask your doctor or study nurse if there is someone on staff who can help you figure out what the cost will be to you. This person may be the study nurse, a financial counselor, or someone in the finance department.

What if I decide the study isn’t the right fit? Can I opt out?

Participation in clinical studies is completely voluntary. It is important to keep in mind that patients may choose to stop treatment at any point during the study.

Who will be overlooking the process?

Along with your regular healthcare provider, a research team composed of other doctors and experts will be administering the study.

How do you find a clinical study?

People learn about clinical studies in different ways. Sometimes, patients are referred by their primary care doctor or oncologist. Some study volunteers are cancer patients who want to try experimental drugs or treatments that aren’t yet on the market. These patients often find information about a clinical study on the Internet and may travel long distances to participate. Clinical studies are not available everywhere. Most are located at major medical centers with a national reputation for quality clinical research programs.