You have just been told your loved one is participating in a clinical study. It is important to note that you may have many questions and that’s okay. While your family member or close friend may not have all the answers, keep in mind his or her medical team will be open to answering your questions as well.
Here are some common questions you may have.
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.
Why did they decide to participate in a study?
Every individual may have a different response as to why they have chosen to participate. In addition to receiving the latest and most innovative treatment available, many participants note helping others or helping advance the future of medicine as one of the main reasons why he or she has decided to take part.
What are the risks/benefits associated with the study?
Just like with standardized treatments, clinical studies have risks and benefits associated with participating.
- 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
- 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
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.
Is it dangerous to participate?
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 we talk to someone who has participated in a clinical study?
They can ask their healthcare provider or nurse and they can try and make that connection.