Frequently Asked Questions About Clinical Trials
A cancer clinical trial is a research study involving human volunteers, in which a new drug, device, vaccine or other therapy is used to determine its safety and effectiveness. The main goal of a clinical trial is to find better ways to help cancer patients fight their disease.
Advances in cancer treatment come from the investigation of new approaches to care. Clinical trials help researchers learn which approaches are the safest and most effective. Nearly all of the drugs we have today to fight cancer were once tested in clinical trials. However, further studies are needed to find even better treatments.
Clinical trials have specific guidelines which tell study doctors who can participate. They generally include: the type and stage of cancer, prior treatment history, age group and current state of health. These guidelines help to ensure that the patient population is similar, so the results of the trial can be attributed to the treatment being studied and not to other reasons unique to each patient.
Choosing to participate in a clinical trial is an important decision. First, you should ask your doctor which trials you may be eligible for. Eligibility is typically based on cancer type, cancer stage, as well as other factors such as age, prior treatment history, and previous or current health issues.
Once it is determined that you may qualify for a specific trial, you should ask your doctor as many questions as possible, such as: the purpose of the trial, treatment schedule and duration, required tests, possible risks and benefits, as well as alternative treatment options. Furthermore, most people find it helpful to talk about their options with those family members or friends they are closest to.
You are the only one who can decide if a clinical trial is right for you. There is no right or wrong answer. Bear in mind that if you decide to participate in a trial, you may change your mind at any time.
Therapeutic trials: These trials test new treatments for cancer such as drugs, vaccines, gene therapies, as well as new methods for surgery and radiation therapy.
Prevention trials: These trials test new interventions such as medicine, vitamins, minerals or herbal supplements to see if a.) they may help prevent or to lower the risk of getting certain cancers, or b.) help lessen the symptoms or side effects of some cancers.
Supportive care trials: These trials examine ways in which a cancer patient’s quality of life may be improved, and focus on helping patients manage common treatment or disease-related issues such as: fatigue, pain, nausea, vomiting, weight loss, or depression.
Screening, Early Detection, or Diagnostic trials: These trials aim to find new ways to detect cancer in people early on, before they start to have symptoms of the disease.
Epidemiologic, Observational or Outcome Trials: These are trials that involve both cancer patients and healthy patients. No treatment or intervention is used, the goal is to learn as much about cancer as possible.
(modified from National Institutes of Health)
Phase I trials: Researchers test an experimental drug or treatment in a small group of people to evaluate its safety and identify side effects. Often these trials are not disease specific and may include more than one type of cancer.
Phase II trials: The experimental drug or treatment is administered to a larger group of people to determine its effectiveness and to further evaluate its safety.
Phase III trials: The experimental drug or treatment is administered to large groups of people (typically in the thousands) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.
(Source: National Cancer Institute)
Clinical trials offer high-quality cancer care. If you are in a randomized study and do not receive the new treatment being tested, you will still receive the best known standard treatment. This may be as good as, or better than, the new approach.
If a new treatment is proven to work and you are taking it, you may be among the first to benefit. You also have the chance to help others by improving cancer treatment.
(Source: National Cancer Institute)
New treatments under study are not always better than, or even as good as, standard care. New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment.
If you receive standard care instead of the new treatment being tested, it may not be as effective as the new approach. Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.
Health insurance and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. To find out in advance what costs are likely to be paid in your case, check with your insurance company and talk to a doctor, nurse or social worker from the study.
Placebos are inactive substances that appear to look like the investigational treatment under study. Placebos are not often used in cancer clinical trials, however if they are used, a patient will always receive at the minimum, standard treatment as well. For example, in some randomized trials, patients will be assigned by chance to either the investigational treatment group or the control group. In the control group, a patient would receive standard therapy plus placebo. In the investigational group, the patient would receive standard treatment plus the investigational treatment. Usually neither the doctor nor the patient knows if they are getting the investigational drug or placebo. This is how clinicians determine if one treatment is more effective than the other.
(For some cancers, standard care may be observation alone, so in this case a patient might get a placebo alone).
For more information about cancer clinical trials, or to learn which trials are available at Cedars-Sinai, you may reach our Clinical Trial Recruitment Navigator by phone at 310-423-2133, or by email at: Cancer.Trial.Info@cshs.org (Once you click on the email address, be sure to select "Cancer Clinical Trials" as your area of interest).