A Patient’s Guide to Clinical Trials

In light of Clinical Trials Awareness Month, which is April, we offer this informational directory on understanding them.

What are clinical trials?

The purpose of a clinical trial is to look for new and better ways to prevent, detect, diagnose or treat a disease. Many trials look at the effect and safety of a treatment. Some look at the link between risk factors and disease. Other trials may look at tissues or blood to learn about a disease, or use surveys to learn how a disease affects daily living. Lastly, there are trials that look for ways to improve the comfort and quality of life of people with a disease.

What are the different types of clinical trials?

Treatment trials test new ways to treat cancer. That may include testing:• A new drug• A new type of surgery or radiation• A new combination of treatments• New methods such as gene therapy• Supplements• Complementary and Alternative Methods, or CAMSometimes extra tissue samples are also taken for additional laboratory studies. An example would be a study that compares a new drug against standard drugs. It looks to see if the new drug treats a type of cancer better and with fewer side effects.Prevention trials test new methods, such as medicines, vitamins or minerals that may lower the risk of a type of cancer. These trials:• Look for the best way to prevent cancer in people who have never had cancer• Look for ways to prevent cancer from coming back• Test ways to prevent a new type of cancer in people who have already had cancerAn example might be a study that uses a drug to see if it prevents a certain cancer.Screening trials test the best way to find cancer in its early stages. An example might include a study that includes one MRI scan of the whole body to find cancers in children instead of doing several CT scans or x-rays.Epidemiologic or observational trials look at the link between risk factors and cancer. Others look at the effect of cancer treatments.Example: A study looks at the effects of medicines on decision-making in patients with cancer.Quality-of-life trials look at ways to improve comfort and quality of life for patients. One example is a study that compares the quality of life of patients who had a bone marrow transplant with healthy people of the same age, sex and schooling.

Pros and Cons

What are the pros and cons of participating in a clinical trial?Pros• You may get promising new treatment methods that you can’t get outside of a clinical trial• New methods may have fewer side effects than usual methods• You are helping others with the same disease, both now and in the future• You play an active role in your own health careCons• New drugs or methods are not always be better than the standard treatment• New methods may have side effects or risks that doctors do not expect or that are worse than those from the standard treatment• If you are in a randomized trial you will not be able to choose whether you get the study treatment or standard treatment• Your health insurance may not cover all costs• You may need to make more visits to the hospital or clinic• No one can promise that a new study treatment may workYou may drop out of a clinical trial at any time, for any reason.

Questions you should ask your doctor:

• What is the reason for doing this trial?• Is this trial going to help me?• What medical tests and/or treatment will be done during the trial and for how long?• What are the pros and cons of this trial?• What are the possible side effects?• What other treatments are available if this doesn’t work?• Have there been other trials using this treatment?• Will my insurance cover the trial costs?• Will I need to make extra trips or visits?• Will I be paid for mileage/hotel costs?• Can the trial be done in my local community?• Can I quit before the end of the trial?• What costs will be covered by the trial?• Will I know what treatment I will be receiving?

Myths and facts about clinical trials:

True or false? Your doctor knows best; he or she can tell you whether or not you should consent to participate in a clinical trial.False. Your doctor is likely to be a valuable source of advice and information, but only you can decide whether to participate in a clinical trial. No one—not even medical experts—can predict whether a treatment, screening, prevention, or supportive care method under evaluation in a trial will prove successful. The informed consent process is designed to help you weigh all of the information and make the right choice for you or your child.True or false? You must be near a big hospital to participate in a clinical trial.False.Many cancer clinical trials take place at local hospitals. Some also take place at local cancer clinics and doctor’s offices.True or false? There are real benefits to participating in clinical trials.True. By participating in a clinical trial, patients have access to the latest drugs or procedures and are among the first to receive potentially effective new therapies. Studies have shown that trial participants have outcomes that are as good as, if not better than, those who do not participate, even if they get the standard of care and not the treatment that is being tested.True or false? Cancer clinical trial patients are often given sugar pills.False.Patients who join clinical trials are given the best treatment available or the chance to receive a new treatment being considered. Sugar pills (also called placebos) are rarely used in cancer clinical trials and are never used in place of treatment.True or false? The informed-consent document outlines all of the possible known risks and side effects of a trial.True. By law, each informed consent document must contain information on all the known risks associated with a trial.True or false? Clinical trial patients are treated like ‘guinea pigs.’ False. Ninety-seven percent of Harris survey participants who took part in clinical trials said that they were treated with respect and received excellent or good quality care. Patients in cancer clinical trials have outcomes as good as, if not better than, those who do not participate.True or false? Health insurance will not cover the costs of a clinical trial.False. Many insurers cover the costs of treatment that they cover if you were not in a clinical trial. Other costs may not be covered. Check with your study coordinator to see if you are covered.True or false? You can drop out of a clinical trial any time you wish.True.You may withdraw from a clinical trial at any time.True or false? Medicare covers the patient care costs of clinical trials.True.Medicare has been covering these costs since June 2000.True or false? A patient can become the subject of a clinical trial without knowing it.False.All patients in a clinical trial are volunteers and must sign an informed consent. Even after signing a consent form, patients are free to withdraw from the study at any time they choose.True or false? Researchers and doctors may not tell the risks associated with a clinical trial.False.Before patients can participate in a clinical trial they must read and sign the informed consent document. This document contains a list of potential risks of each trial.True or false? Many cancer patients are not aware of clinical trials when they decide on a treatment plan.True.A National Study by the Lung Cancer Alliance showed that 80% of study participants were not aware of available and appropriate clinical trials at the time they were exploring treatment options.True or false? Cancer clinical trials are for people who have no other options.False.Trials are often another option that offers a treatment plan that may better address the patient’s needs and continue their quality of life.