What You Need to Know About Clinical Trials A Guide for People With Cancer

Developed by Pfizer in partnership with the Colon Cancer Alliance. What You Need to Know About Clinical Trials A Guide for People With Cancer THE VOICE OF SURVIVORS

Why You Need to Know About Clinical Trials As a person with cancer, or a loved one of that person, it s important to be well informed. You need to know about all your treatment options. This includes treatments that may be offered through clinical trials. A clinical trial may offer you a new treatment option. Whether you decide to take part in one is up to you. This booklet is all about clinical trials. It will help you decide if a clinical trial is right for you.

What Are Clinical Trials? How Are Clinical Trials Conducted? Clinical trials are research studies. They are done with volunteers. They look for better ways to prevent, screen for, or treat a disease. Cancer treatment clinical trials test new: Medicines (chemotherapy and other drugs) Approaches to surgery or radiation therapy Combinations of treatments Methods of treating cancer, such as gene therapy A treatment is tested before a clinical trial starts. The tests are done in labs or on animals. They check to see how safe and effective the treatment is. The new treatment must be as good as or better than standard ones. The standard treatments are the best ones available to people. Why Are Clinical Trials Important? Clinical trials are important. Cancer treatment clinical trials: Contribute to progress in the understanding of and fight against cancer Answer important scientific questions and lead the way for future research efforts Determine if a particular treatment is safe and effective May help the people who take part extend or improve their lives Strict scientific and moral standards guide clinical trials. These standards are designed to: Produce credible research Protect the rights and well-being of participants To ensure these goals are met, every clinical trial has: 1. A protocol (PRO-tuh-call), or action plan, that outlines: What will be studied Why and how it will be studied Who will take part and how they will be chosen How results of the trial will be evaluated The trial must always use its protocol. Many groups sponsor (fund) clinical trials. They approve the protocol, too. Trial sponsors include: The National Cancer Institute (NCI) Pharmaceutical and biotechnology companies Medical institutions (such as hospitals or clinics) Individual doctors Partnerships between universities, government agencies, or doctors and pharmaceutical or biotechnology companies Private or government organizations 4 5

An Institutional Review Board (IRB) also approves the protocol and: Includes health, clergy, and community members Makes sure the trial is fair and safe 2. Eligibility criteria, or guidelines, which often include: Age Sex Type and stage of cancer Medical history Current health status Each trial has its own set of guidelines. They say who can be in a clinical trial. 3. Phases of research Most clinical trials go through a series of steps called phases that include: PHASE 1 TRIALS During this phase, the new treatment is tested to find out: Whether the treatment is safe and if so, the amount (dose) that is safe to take How it should be given (eg, by mouth or injection) and how many times a day Whether the treatment has any harmful side effects Include only a small number of people not helped by other treatments Usually take place at only a few locations 6 PHASE 2 TRIALS Test how well the new treatment works (eg, if blood test results improve) Usually include fewer than 100 participants PHASE 3 TRIALS Compare results (eg, better survival rates, fewer side effects) of people on new treatment with people on standard treatment May include hundreds or even thousands of people Take place all across the country In Phase 3, researchers assign you to the new or the standard treatment by chance. If you get the new one, you re in the treatment group. If you get the standard treatment, you re in the control group. This process is called randomization (ran-duh-mih-zayshun). It is done to avoid bias (BY-us). Bias means human choice or other factors that might affect the trial results. To reduce bias more, you may not know what group you re in. This is called a single-blind trial. Only the doctor knows who is getting which treatment. Sometimes not even your doctor knows what group you re in. This is called a doubleblind trial. 7 Might I Get Just a Placebo? Sometimes people worry that they will get just a placebo (pluh-see-bo) or sugar pill in a clinical trial. That does not happen in trials that compare cancer treatments. You will get either the new treatment or the best standard treatment.* In fact, you will get expert care from a team of health care professionals. This care can be better than regular treatment care. *If no standard treatment exists, you may get a placebo. But you must agree to it first.

What Rights and Protections Do I Have? All clinical trials have rules that protect you and your rights. It s important that you know what they are. Taking part in a clinical trial is up to you. It is strictly voluntary. If you do take part, you will be carefully watched throughout the trial. If at any time a treatment is found to be harmful, it will immediately be stopped. Then you may get other treatment from your own doctor. You may leave a trial at any time you choose. You will also get an informed consent form. It lists the key facts about the trial. If you decide to take part in a trial, you must sign this form. (However, even after you sign the form, you can still leave the trial any time you choose.) Is Participating in a Clinical Trial Right for Me? Taking part in a clinical trial is up to you. Family, friends, and your health care providers can help you make the decision. Knowing what the possible risks and benefits are will help you decide. Informed Consent: Protecting Your Rights Before deciding whether to take part in a clinical trial you go through a process called informed consent. Informed consent means you will get: All the facts about a trial before you decide to participate, including: The exact plan for each step of the trial Details about the treatments and tests you may receive Possible side effects Possible benefits and risks How the trial may affect your daily life Any new findings, like new risks, about your trial while it is going on 8 Consider the Pros and Cons What Are the Possible Benefits? There are a lot of good reasons to take part in a clinical trial. As a participant, you: Will receive high-quality cancer care May be among the first to benefit from a new treatment Have some portions of treatment paid for by the clinical trial Are taking an active role in the management of your care Have the chance to improve cancer treatment and help others 9

What Are the Possible Risks? There are some risks in being part of a trial, too. You may: Receive new treatment that turns out to be not as good as the standard treatment (The risk varies depending on the phase of the trial. There is much less risk in Phase 3 trials.) Receive the standard treatment that you would have received outside of the clinical trial (If the new treatment is proven better than the standard treatment, you will be quickly changed to the new treatment.) Have unpleasant side effects that are different from the side effects from standard treatment Not get all your costs covered by insurance Ask the Right Questions Talk to your health care providers about any clinical trial you are considering. Talk to the trial s staff as well. Bring a list of questions and write down the answers you get. You may also want to bring someone else or a tape recorder with you. Questions you may want to ask about being in a clinical trial include: What is the goal of the trial? What are the treatment choices in the trial? How does the new treatment work? What are the benefits? What are the risks? What other treatment choices do I have? How often and for how long will I receive the treatment? How long will the trial last? Where will the trial take place? Will all my costs be covered?* What were the results of previous trials for this treatment? 10 Use this space to write down other questions you may have. Clinical Trials: Consider the Opportunity In the past, some people thought clinical trials were just for people who had no success with other treatments. They saw clinical trials as a last resort. Now, many choose a clinical trial first. They see it as an opportunity. They want to take advantage of it. Today, people with advanced colon cancer get new, better treatments earlier. Ask about clinical trials. Ask before you start standard treatment. If you don t, you may have to wait to be in a clinical trial. Taking part in a clinical trial is up to you. But, you owe it to yourself to consider it. It may be one of the best choices you can make for yourself and for others. It has been for many people. 11 *All your costs may not be covered by health insurance. You can find out. Ask your health care provider or social worker. For more information You can learn more about cancer research and clinical trials. Ask your doctor for more information and for trials that might be right for you. You can also get information by phone or through the Internet. Contact: The National Cancer Institute (NCI) Toll free: 1-800-4-CANCER (1-800-422-6237) TTY (for deaf and hard of hearing callers): 1-800-332-8615 www.cancer.gov The American Cancer Society 1-800-ACS-2345 (1-800-227-2345) www.cancer.org