A Patient's Guide to Clinical Trials
Clinical trials are an important step to finding safer and more effective treatments for cancer and ways to detect cancer earlier. Less than 5% of patients with cancer take part in a clinical trial
Clinical trials are an important step to finding safer and more effective treatments for cancer and ways to detect cancer earlier. Less than 5% of patients with cancer take part in a clinical trial. Some are not sure how to find a trial, whereas others have concerns about treatment safety. We answer common questions patients have about clinical trials, define clinical trial terms, and list online resources that match patients with appropriate trials. Be sure to discuss any concerns you have about clinical trials with your physician. Words in blue are defined in the Glossary on the next page.
What is a clinical trial?
Many clinical trials are designed to assess a treatment’s safety and effectiveness in humans. Others try to identify genes that help predict cancer, look for ways to improve how cancer is diagnosed, or investigate better ways to care for people with cancer. Most clinical trials take place only after laboratory and animal testing have demonstrated that a new therapy destroys cancer cells and appears safe. Clinical trials are one of the last steps before a company seeks approval for a particular treatment against a particular disease.
Why consider a clinical trial?
In addition to helping advance cancer research, there are many reasons to consider participating. You will be able to play a more active role in your healthcare, you can gain access to new—and possibly more effective—research treatments before they are available commercially, and you will receive attentive follow-up care from physicians, nurses, and other health professionals who specialize in cancer. Clinical trials are no longer viewed as a “last resort” for patients, and some patients receive their initial treatment through a clinical trial.
Is it safe to participate in a clinical trial?
Clinical trials do have certain risks. Some patients do experience unpleasant, serious, or life-threatening reactions to an experimental treatment, referred to as adverse effects or side effects. Common side effects associated with standard cancer treatments include fatigue, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores. New treatments may have these and/or other unknown side effects. The research team will discuss possible short- and long- term side effects with you before the trial. For some patients, the trial medication might not be effective or may be less effective than standard treatment. The study team will monitor your safety and the cancer’s response to the treatment closely. They will help you manage adverse effects and discuss your options if the treatment proves ineffective.
What is informed consent?
Before you decide whether to take part, the research team will review the informed consent document with you. This describes all of the study’s important details, including purpose, protocol, risks, and possible benefits. You are encouraged to ask any questions you have about the study. Patients who decide to participate will need to sign the informed consent document; it is not a contract, however, and you may leave the study at any time.
Could I end up with a placebo?
In a cancer clinical trial, patients will receive the best standard treatment available or a new treatment believed to be as good or better. In a trial where patients are randomly assigned to different treatment groups, it is rare that one group would be given placebo alone, without an active treatment, unless no standard therapy exists for the type of cancer being studied. The research team will discuss the treatment options with you before you decide whether to participate.
Who sponsors clinical research?
The National Cancer Institute, a federal agency, wholly or partially funds many cancer clinical trials. The Department of Veterans Affairs, medical centers, pharmaceutical companies, and foundations also sponsor trials.
What does it cost to participate in a trial?
Patients’ costs may vary according to the type of health coverage they have, the state they live in, and who is sponsoring the trial. You will be responsible for any expenses not covered, so it is important to speak with a financial counselor before agreeing to participate. Some health insurance plans cover tests associated with routine care according to the terms of the plan but may not cover medications prescribed to treat side effects or procedures not deemed “medically necessary.” The trial sponsor generally covers tests performed to satisfy the trial’s research requirements and new drugs or agents under investigation, and may reimburse you for travel time and expenses. Medicare covers all routine costs for subscribers participating in a Medicare- qualified clinical trial. If your health plan refuses to cover certain expenses, ask someone from the research team to talk with the plan’s representatives.
How do I find a trial?
If you are interested in participating in a clinical trial, speak with your nurses or visit these Websites for additional information or assistance:
• Cancer.org, (800) 303-5691
• Emergingmed.com (Ovarian Cancer National Alliance), (800) 535-1682
• Cancer.gov/clinicaltrials, (800) 4-CANCER
• CancerTrials4Prostate.org, (877) 298-4185
Glossary
Adverse effects/side effects—Undesired effects or reactions to treatment, which range from minor, to serious, to life threatening.
Blind study—When the participant does not know what treatment he/she is receiving.
Control group—A selection of patients given standard treatment or placebo rather than the experimental therapy.
Eligibility criteria—Standards for determining whether a person is allowed to enter a clinical trial.
Interventional study—Investigators assign patients to a treatment or other intervention and measure outcomes.
Observational study—Investigators observe (but do not treat) patients and evaluate their outcomes.
Open-label study—When the physicians and patients know which treatment the patient is receiving.
Placebo— Inactive “sugar” pills or injections with no treatment value.
Protocol—Study plan for the clinical trial, outlining who is eligible to participate; the schedule of tests, procedures, and medications; and the length of the study.
Randomization—A method that relies on chance to determine which participants are assigned to which treatment group.
Sponsor—Organization providing resources for the clinical trial.
Standard treatment—An FDA-approved treatment currently in wide use and considered effective therapy for a specific disease or condition.
