Cancer Clinical Trials FAQ
In the past, clinical trials were viewed as last resort. Today, patients often choose to receive their first treatment in a clinical trial. Evidence shows that patients who participate in clinical trials often benefit more than those who don't.
To help answer any questions you may have as you consider a clinical trial, please see the frequently asked questions below.
- What are clinical trials?
- What are the phases of clinical trials?
- Why are clinical trials important?
- Should I participate in a clinical trial?
- How will I know if I'm eligible to participate in a clinical trial?
- What exactly is a placebo, and do cancer patients ever receive placebos in a clinical trial?
- What are the benefits of participating in a clinical trial?
- What are the risks of participating in a clinical trial?
- What are my rights and responsibilities while participating in a clinical trial?
- Do I have to pay to participate in a clinical trial?
- Who sponsors clinical trials?
- Who regulates clinical trials?
- What are some key terms to know?
What are clinical trials?
Clinical trials are research studies that test new cancer drugs, treatments, diagnostic procedures and therapies on humans. Before any new medication is made available to the public, it must undergo a clinical trial. Strictly monitored and carefully evaluated, clinical trials test the therapy's safety and efficacy.
Your oncologist and the highly skilled physicians at Virginia G. Piper Cancer Center Clinical Trials will help you determine if you should participate in a study.
What are the phases of clinical trials?
Before any medicine is made available to the public, it must undergo a clinical trial. Clinical research consists of four phases:
- Phase I trials evaluate how a new drug should be given (by mouth, injection into the blood or into the muscle), how often the drug should be given and amounts for a safe dosage. A Phase I trial usually enrolls only a small number of patients.
- Phase II trials continue to test the safety of the drug and begin to evaluate how well the new drug works on a particular kind of cancer. In a Phase II trial, the study drug or treatment is given to larger groups of people (100-300).
- Phase III trials compare the results of individuals taking the new drug with the results of those taking the standard treatment. In a Phase III trial, the study drug is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments. Researchers collect information that will allow the drug or treatment to be used safely. The time frame for this phase is usually several years.
- Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the drug or treatment to collect information about its side effects in various populations and any side effects associated with long-term use.
Why are clinical trials important?
Clinical trials are important for two reasons: 1) Patients who participate may be helped by the treatment they receive. Trial participants have access to the latest drugs, procedures and other types of treatment. Although there's no guarantee that a new treatment will be effective, many trial participants conclude that the possible benefits outweigh the risks. 2) Clinical trials contribute to the overall knowledge and progress of the disease or condition being studied.
Should I participate in a clinical trial?
Whether you participate in a clinical trial or not is ultimately your choice. By discussing all of your options with your oncologist and the cancer care team at Virginia G. Piper Cancer Center Clinical Trials, you'll be better able to make a decision that's right for your unique situation. At any given time, numerous current clinical trials are in progress at our program. Ask your doctor if any of them might be right for you.
How will I know if I'm eligible to participate in a clinical trial?
Each clinical trial has eligibility criteria — requirements that patients must meet before they can participate. Eligibility criteria might include information about:
- Age and sex.
- Type of cancer.
- Stage (extent) of the cancer.
- Previous treatments that you must, or must not, have had.
- Length of time since you last received treatment.
- Results of certain laboratory tests.
- Medicines you're taking.
- Other medical conditions.
- Previous history of any other cancer.
- Other conditions specific to each clinical trial.
What exactly is a placebo, and do cancer patients ever receive placebos in a clinical trial?
A placebo is a substance that looks like medicine, but is not. Cancer patients in a clinical trial always receive the best standard treatment available or a new treatment that researchers believe is as good or better. Only in specific circumstances are cancer patients given placebos in a randomized trial. If a placebo is used, researchers may give patients in the control group a placebo in combination with standard treatment to compare standard treatment alone to standard treatment with a new drug.
What are the benefits of participating in a clinical trial?
As a clinical trial participant, you will:
- Be closely monitored by the study coordinator and physician.
- Have the opportunity to receive a new medication to treat your condition.
- Learn more about your disease or condition.
- Learn about the latest advances in treating your condition.
- Contribute to the advancement of medical care.
What are the risks of participating in a clinical trial?
Before taking part in a clinical trial, talk with your doctor about some of the risks involved with treatment. For example:
- New drugs or treatments may not be better than the standard care with which they are being compared.
- New treatments may have unexpected side effects and may be worse than those of standard treatments.
- You may be required to make more frequent visits to the doctor.
What are my rights and responsibilities while participating in a clinical trial?
It is your choice to participate in a clinical trial. Likewise, you may choose to leave a clinical trial at any time. If you plan to stop participating, let the research team know why you're leaving the study.
Before entering a cancer clinical trial, you should know as much as possible about the research study. It's important for you to feel comfortable asking questions, and the staff should answer them in a way you can understand. Some of your questions might be:
- What are the possible immediate and long-term side effects?
- What other treatment options do I have?
- Will I have to pay anything to participate in the study?
- What are the charges likely to be?
- Is my insurance likely to cover those expenses?
Do I have to pay to participate in a clinical trial?
You'll be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Therefore, be sure to ask the principal investigator or research nurse specifically about which costs will be your responsibility if you decide to participate in a clinical trial.
The clinical trial sponsor (whether it's the government or a company) may pay for the experimental treatment, special testing and extra doctor visits.
Some health insurance companies will cover the costs of procedures that patients would have even if they were not in a clinical trial (routine costs that are considered "standard of care"). For Medicare patients, routine costs are covered in all Medicare-qualified clinical trials.
Who sponsors clinical trials?
Clinical trials can be sponsored by government agencies, pharmaceutical companies, individual physician-investigators, healthcare institutions, and universities, organizations that develop medical devices, doctor's offices or community clinics.
Who regulates clinical trials?
The U.S. government has strict guidelines and safeguards to protect individuals who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by a local Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is an independent committee of physicians, statisticians, community advocates and others who ensure that a clinical trial is ethical and that the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
What are some key terms to know?
- Bias — Human choices or any other factors, besides the treatments being tested, that affect a study's results.
- Clinical trials — Research studies that test new cancer drugs, treatments, diagnostic procedures and therapies on humans. Before any new medication is made available to the public, it must undergo a clinical trial. Clinical trials are strictly monitored and carefully evaluated, and test the therapy's safety and efficacy. Your oncologist and the physicians at Scottsdale Healthcare Research Institute will help you determine if you should participate in a clinical trial.
- Control group — In a clinical trial, the group of people that receives standard treatment for their cancer.
- Informed consent — The process in which a person learns key facts about a clinical trial or research study and then agrees voluntarily to take part or decides against it. This process includes signing a form that describes the benefits and risks that may occur if the person decides to participate.
- Institutional Review Board (IRB) — Groups of scientists, doctors, clergy and consumers at each healthcare facility at which a clinical trial takes place. Designed to protect patients who take part in studies, IRBs review and must approve the protocols for all clinical trials funded by the federal government. IRB members check to see that the study is well designed, does not involve undue risks, and includes safeguards for patients.
- Investigator — A researcher in a treatment study.
- Oncologist — A doctor who specializes in treating cancer.
- Placebo — A tablet, capsule or injection that looks like a drug or other substance being tested but contains no drug.
- Protocol — An action plan for a clinical trial. The plan states what will be done in the study and why. It outlines how many people will take part in the study, what types of patients may take part, what tests they will receive and how often, and the treatment plan.
- Randomization — A method used to prevent bias in research. People are assigned by chance to either the treatment or control group.
- Remission — When the signs and symptoms of cancer go away, the disease is said to be "in remission." A remission can be temporary or permanent.
- Side effects — Problems that occur when the treatment affects healthy cells. Common side effects of standard cancer treatments are fatigue, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores. New treatments being tested may have these or other unknown side effects.
- Single blind study — A method used to prevent bias in treatment studies. In a single blind study, the patient is not told whether he/she is taking the standard treatment or the new treatment being tested. Only the doctors know.
- Stage — The extent of a cancer and whether the disease has spread from the original site to other part of the body. Numbers with or without letters are used to define cancer stages.
- Standard treatment — The best treatment currently known for a cancer, based on results of past research.
- Treatment group — The group that receives the new treatment being tested during the study.
If you have questions or concerns, please contact us.
For additional information about available clinical trials, contact an oncology nurse navigator at 480-323-1339 or 877-273-3713.