A: Cancer clinical trials are designed to help find new ways to prevent, detect, or treat cancer. One major purpose is to determine whether a new treatment option is safe and effective and effective and to improve treatment over current cancer therapies.
A: Clinical trials test the safety and effectiveness of new treatment options (new treatments or old treatments used in new ways) not yet approved for general use. Standard care is a non-experimental treatment option that has been proven effective and is currently being used. Likely, the standard care being used was proven effective based on past clinical trials.
A: Development of a new treatment progresses in an orderly series of steps, called phases. Clinical trials done at UVMCC are usually classified into one of three phases:Phase I trials involve a small number of human subjects who receive a new treatment that has already undergone rigorous testing in animals. The goal of phase I trials is to determine the safest dosage and schedule of treatments for further studies. Phase I trials typically offer little or no benefit to participants.Phase II trials build on phase I trials and therefore involve a drug who dose and side effects are more well known. They involve larger groups of participants, and because of this, investigators may discover less common side effects and will continue to evaluate the safety of the treatment. During phase II, the effectiveness of the treatment can also be estimated. Some participants may experience benefit from a phase II trial.Phase III trials may involve hundreds of patients, often at several medical institutions. During this phase, the study treatment is compared to standard treatment methods. Some participants are given the experimental drug while other participants receive best existing treatment, also known as the standard of care. This allows researchers to determine if one treatment seems to be better than the other. If the experimental drug provides a better outcome in some way than the standard of care drug, an application may be made to the FDA to allow the drug to be prescribed for its studied use.
A: Scientists study ways to prevent, detect, diagnose, control, and treat cancer. They may also measure the psychological impact of cancer and determine ways to improve a patient’s comfort and quality of life. Many clinical trials study new treatments; they may be studied alone or along with surgery, radiation therapy, chemotherapy, or newer types of therapies.
A: Risks and side effects exist with almost any treatment whether it is standard care or an experimental treatment being studied in a clinical trial. The risks with a clinical trial may be greater, because any new treatment has more unknowns and there is always a chance that the new treatment will not be as good as standard treatment or not work at all. In considering participation in a clinical trial, it may be helpful to look at two things:
Your doctor should be able to answer both of these questions for you. Information about these risks are also provided in writing to patients considering participation in a trial. However, particularly in early phase trials, there is always a risk of unknown side effects.
A: Many safeguards are in place to make clinical trials as safe as possible and to protect patient rights. Before a new treatment is tried with patients, it is carefully studied in the laboratory. Laboratory research can help determine how best to use the new methods with people safely and effectively. Every clinical trial must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and that they do not outweigh the potential benefits. Any research involving people at the University of Vermont Cancer Center is reviewed approved by an IRB prior to any patients being enrolled. The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the public who periodically review the research for your safety. The IRB is authorized by the FDA to review, require changes to, approve, or disapprove clinical trials. Researchers must follow the plan approved by the IRB exactly, and you will know the details of that plan prior to joining the clinical trial.Additionally, clinical trial participants are carefully monitored. If you participate in a trial, blood tests, x-rays, and other procedures are usually performed regularly to detect and record any changes, good or bad, in your condition.
A: By participating in a clinical trial, you are being offered the chance at a drug not yet available to others with your condition. If the new drug does what researchers hope it will do, you may be one of the first people to benefit from the new drug. It is important to know that not all trials will provide direct benefit. Even when an experimental treatment, prevention approach, or diagnostic test demonstrates benefit for some people, not every single patient will benefit just as not every patient will benefit from standard care treatments. Some participants in clinical trials report that they derive an emotional benefit from taking an active role in their own healthcare, and knowing that their participation in a clinical trial may help future patients. Every patient who participates in a clinical trial makes a valuable and lasting contribution to research and healthcare.
A: Your physician or nurse may suggest a clinical trial as part of your treatment plan. Deciding whether or not to participate in a clinical trial can be a very hard decision and the answer won’t be the same for everyone. If you are interested in participating, your doctor and his/her research team will help determine whether you are eligible to participate in a specific clinical trial. Every clinical trial has strict guidelines that spell out who can participate; these are called eligibility criteria. The factors that allow you to participate in a clinical trial can include things like age, gender, the type and stage of your disease, previous treatment history, and other medical conditions. If there is a specific clinical trial you are interested in, you should discuss it with your physician. For more information about clinical trials at the University of Vermont Cancer Center, contact the Clinical Trials Office at (802)656-4414.
A: A placebo is a harmless pill or other substance that has no therapeutic effect. Placebos alone are rarely used in cancer treatment trials, but may sometimes be given along with another treatment. No one is ever given a placebo alone when an effective treatment is available to treat his or her cancer. In very rare cases, a placebo may be used when testing a new drug if there is no known effective treatment for the specific cancer type or stage. If a trial does use a placebo, you will be fully informed that the trial includes the possibility of a placebo before taking part in the trial.
A: Patients generally do not have to pay extra out-of-pocket costs for treatments studied as part of a trial. Every trial is different, but the clinical trial’s sponsor (the person or company funding the trial) usually pays for all research-related costs and any special testing. Typically, you or insurance company are asked to pay for any routine tests, treatments, or procedures that would be required as part of standard cancer treatment. Some clinical trials will require you to come to the UVM Cancer Center more often. In these cases, it is possible you will spend more on travel related expenses (e.g., gas, meals, etc.) than if you were not participating in a clinical trial. Before you join a clinical trial, you will receive an informed consent document that spells out exactly what you will have to pay for if you participate in the study.
A: Your participation in any clinical trial is completely voluntary. If you decide you are interested in participating in a clinical trial, you will be provided with an informed consent document that explains the study in easy to understand terms. Informed consent is the process of learning about the clinical trial before you decide to take part in it. Your doctor and the research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records. If you want to participate, you will sign a consent form that details all of the information that has been discussed with the research team. A big part of the process is making sure that you understand what you are signing, have the chance to ask questions and have them answered, and are comfortable with your decision. If you want to take a copy of the consent form home to share with family, friends, or others before signing it, that is encouraged. Once you sign the consent form, a copy is given to you. You will be able to take it home and refer to it at any time. The consent form will have contact information for your study team and others who can help if you have a concern about the trial. Informed consent is ongoing. This means, if the researchers learn new information during the trial that you should know or may impact your willingness to participate in the trial, they will always tell you. Sometimes that may mean you have to sign updated versions of the consent form with this new information included.
A: Yes, you can stop your participation at any time without penalty or risk to the quality of your care. Your study team may ask you to sign a document stating your wish to stop your participation.
A: This is when researchers assign patients by chance, like flipping a coin, to one treatment or another. Neither your physician, nor you, have a say in which treatment you will receive. Because of that, randomization helps avoid bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatment being tested. For example, if doctors could choose which patients to assign to which groups, some might assign healthier patients to one treatment group and sicker patients to the other treatment group, without meaning to. This might affect trial results. Randomization helps ensure that this does not happen.
A: Generally, most clinical trials require you to come to the same clinic you would come to for your routine care. Your regular doctor and nurse are often part of the team that cares for you. In addition, you will also have research coordinator and often a research nurse participating in your care, collecting information for the study, and acting as resources for any questions you may have during your time on the study. Every trial is different. Some clinical trials may require more tests and office visits that you would have if you were having standard treatment. Other trials will not require any more time. Depending on the trial you may also be asked to fill out questionnaires or keep a log or diary about medications you have taken or the status of your health. Many clinical trials will want to continue follow you after your treatment is over, because valuable information for your care and the research may be collected during this time. Before you decide to join the trial, information will be provided to you describing exactly what will happen during the trial.
A: Why is this trial being done? Why are you recommending this trial to me? How long do I have to make up my mind about joining the trial? Why do the doctors who designed the trial believe that the treatment being studied may be better than the one being used now? Why may it not be better? How is it different? What are my other treatment choices, including standard treatments?How long will I be in the trial?What kinds of tests and treatments are involved?What are the possible side effects or risks of the new treatment?What are the possible benefits?How will the doctor know if the treatment is working?What costs will I be responsible for and what will be covered by my insurance or the study? How could the trial affect my daily life?How often will I have to come to the hospital or clinic and is it more often than if I had standard of care treatment?Will I have to travel long distances?What are my responsibilities during the trial?Who will have access to my information and how is it kept private? Will I be told about the trial’s results?
A: There is always someone available at UVMCC available to answer questions about clinical trials. Please contact us at: (802) 656-4414 ext. 2
Clinical trials are the best option for many patients with cancer. Learn more about the benefits of participating and the five most common myths about clinical trials.
