 Each year, over a million Americans from all walks of life learn that they have cancer. At first, many react to the diagnosis with fear. My first reaction when I heard on the telephone that I had cancer was, oh my God, I have cancer? I'm going to die a terrible death. No one had ever talked about cancer because it was something that was a frightening word in our community. When I first heard of cancer years ago, it meant that you had a terminal situation. Having gone through what I've gone through and having studied and read quite a bit, not only about breast cancer but other types, I realized that cancer isn't a death sentence, but more like an obstacle in your life. More than 10 million Americans are living with cancer more than ever before. It can be a difficult battle, but many are winning thanks to significant advances in medical research. Researchers are continuing to make important discoveries that result in new advances in treatment, surgery, chemotherapy, radiation, immunotherapy, and the development of new drugs. One way patients get access to promising new therapies is by participating in clinical trials, also known as cancer research studies. The doctor recommends that you participate in a clinical trial. You are being offered the ability to go one step further than a standard treatment. To do a little bit more, and even though it's not proven, it may benefit one. For me, participating in the trial was about receiving treatment, but with a lot of special attention. These and many other individuals were touched by cancer. Some were empowered to benefit from new treatment options. All were empowered to help others. Rural and urban, sick and healthy, young and old, and everyone in between. Empowerment, access, and choices. That's what clinical trials and the people who make them happen are all about. But clinical trials may not be the best choice for everyone. I chose not to participate in a clinical trial because I was too scared to try something experimental. We looked at the distance and the fact we need to travel to treatment visits for weeks at a time. It seemed like a lot to put my family through when I could just go to the cancer center near my house. And you know, it was a bit scary to think about trying a new treatment, so it was a tough decision. The decision to participate in a clinical trial should be made with your family and doctors to weigh the possible benefits with risks or drawbacks. Ultimately, it's your personal decision whether or not to participate in a clinical trial. Clinical trials test promising new therapies with people in various stages of cancer, from first diagnosis to advanced disease. Patients may learn about clinical trials from their doctor or on their own through libraries, information lines, and the internet. A clinical trial is a test to see if a drug or treatment will be effective in treating human disease. 100% of the people who take a medicine or treatment for a disease are standing on the shoulders of someone who participated in a clinical trial. Clinical trials are an essential part of proving that any new medicine or treatment works for the group it's intended to help. Many of today's accepted uses of medicines came through clinical trials. In the 1970s, for instance, doctors and nurses began to think that Aspirin might save the lives of people who came to the hospital having a heart attack. Because thousands of patients agreed to participate in the clinical trial of Aspirin more than 30 years ago, doctors today routinely give Aspirin to hundreds of thousands of patients every year. A cancer clinical trial is one of the final stages in the careful process of cancer research that begins in the laboratory. When doctors first discover a promising approach, it's often tested on animals. But treatments that work well on animals don't always work well on people. So it's important to study them in cancer patients to find out whether they're safe and effective for people. For the patient's safety, new treatments are tested in four phases. Each phase is designed to answer different research questions. A phase one trial is done with a small number of people. Here we try to find a safe dosage, decide exactly how and when the new medicine should be given, and observe how the new treatment affects the body. Phase two trials determine the effect of the treatment on specific types of cancer. If a treatment shows potential benefits, it goes on to a phase three trial. These trials are open to large numbers of patients, and researchers use them to directly compare new treatments with standard treatments. This results in new standards for care. Finally, phase four trials aim to further assess the long-term safety and effectiveness of a new treatment. There are many types of clinical trials, but all are designed to answer questions about new ways of finding and diagnosing, treating, and preventing cancer. Cancer is many stages. It's a very complicated disease. And at every stage of cancer, we are able to have clinical trials. There are clinical trials for prevention of cancer. There are clinical trials for initial treatment, relapsing, relapsing the second time. It's not true that clinical trials are only for people in the final stages of the disease. For some people with cancer, there are clinical trials that look at better ways to manage symptoms or improve their overall quality of life. I've been fighting breast cancer and have had a lot of side effects from chemotherapy. I took part in a clinical trial to help me feel less tired from the chemo, and it helped me. Before you're offered the option of participating in a clinical trial, there are many considerations. First, researchers must determine whether you meet their trial's specific eligibility criteria. Now, this refers to a list of factors that a patient must have to ensure that the treatment is tested in similar people. The eligibility criteria vary for each trial and may include factors such as type and stage of cancer and whether the cancer patient has had prior cancer treatment or other health problems. Before you can participate in a trial, you may need to visit the clinic for tests and have your current doctor work with the study team. Now, this helps to ensure that a particular study is a good choice for you. You may find that even though you participate in a cancer clinical trial, you may not receive the new treatment. This is due to the process of randomization, which helps ensure that different treatments are evaluated fairly. Randomization is done in all Phase 3 and some Phase 2 trials. Randomization means that patients are assigned to either an investigational group or a control group. Your assignment will be determined by chance through a computer program or a table of random numbers. If you are assigned to a control group, you will get standard treatment. And if you are assigned to the investigational group, you will get the new agent or intervention being tested. To help protect participants and produce sound results, clinical trials are carried out according to strict scientific and ethical principles, with many levels of review throughout the process. Participating in any research study has inherent risks. To protect patients, clinical trials follow strict guidelines. These guidelines, called a protocol, act as a recipe for conducting a clinical trial. The protocol ensures that all patients in the study are treated in the same way. Also for the patient's safety, each study must be first approved by an institutional review board, or IRB, made up of leading researchers and community leaders. Some trials continue to be monitored by a data, safety and monitoring board to ensure the trial is being conducted correctly and to monitor the results closely. An important part of a clinical trial is a process called informed consent. During this process, your doctor or nurse will explain to you in detail the terms and treatments in the study. They'll also answer any questions you may have. Now once you fully understand the study, its potential risks and benefits, and your rights as a participant, you'll be asked to sign a consent form. This form makes sure you understand and agree to the terms of this study. You may want to discuss the form with family or friends, or bring someone to the doctor's office with you. It is very important to keep asking questions until you fully understand the terms of the study. If you choose to participate in a clinical trial, you have the right to leave the study at any time, even after signing an informed consent agreement. That was made clear from the beginning that I don't have to go... I could say stop at any time. I don't have to go through anything that I don't feel comfortable with or I'm afraid of. The safety of participants in the trial will continue to be monitored throughout the study. If the review board or data and safety monitoring board finds that a trial appears to be causing unexpected harm to the participants, the board can stop the trial. The idea that clinical trials are only for the very ill is one of many misconceptions surrounding clinical trials. Another myth, based on fear, is a myth that patients who enroll in clinical trials are treated like guinea pigs. That's actually been said to me before, you know, I could never do that because, you know, they're just... they're trying out weird stuff on people and that's really not true. Another misconception involves the use of placebos or sugar pills in place of treatments a patient may need. Placebos are almost never used in cancer treatment clinical trials. In some cases, a study may compare standard therapy plus a new therapy to standard therapy plus a placebo. You will be told if the study uses a placebo. At any point during the trial, if one of the groups is doing better than the other, the trial will be stopped and all patients will be offered the opportunity to receive the better treatment. Of course, as promising as a new drug or treatment may seem, entering a clinical trial is a decision to consider carefully. You may want to think about such things as cost you may be responsible for, time commitments, and the number of doctor visits required. One concern in considering clinical trials is the cost involved. Some insurance companies state that they don't cover experimental treatments. Before you participate in a clinical trial, check with your insurance company about whether this expense is covered by your plan. Insurance coverage is not always a requirement. Even those who are uninsured may be able to participate in clinical trials. Assistance may be available through sources such as the group running the trial or Medicare. You also can talk to a nurse or a social worker from the study. They will help you be sure of how cost for participation will be covered. When you're considering participating in a clinical trial, your current doctor may be able to help you. Here are some questions you may want to ask. Find out about the trial, how long will it last, what's involved, and what are the possible side effects or risks. What are the costs and what will you need to pay for as opposed to your insurance company? How will the trial impact your daily life including the time and travel commitment you'll need to make? What other treatment options are available and how do they compare to the treatment in this trial? Patients in clinical trials are monitored very closely. In some trials, patients may have to come in more frequently for tests and check-ups. Sometimes these demands can mean a greater commitment in terms of time and travel. Most patients find that life as they know it changes during a clinical trial, much as it does with standard cancer treatments. Many people have to cut back on work and family activities. Although the change may only be temporary, for active people it can be difficult. You may have to travel a long distance. Is it going to fit into your lifestyle? You may be the breadwinner of the family. How's that going to impact? And all of that has to be laid out before the patient so that they can decide. I didn't go into this without any fear, trust me. But I feel like the fear made me more aggressive in my treatment and now has given me a peace of mind that I have done the most that I can do to battle this disease. During the decision-making process, many patients find it helpful to gather as much information as possible from every available source. If you want to know the truth, I actually make my decision upon the recommendation of my doctor. I would also suggest that if a doctor recommends you for a trial to ask him for some names of people that have already been through it, I had quite a few people call me who were on the line trying to decide whether they should go into it or not. And I tried to give them the best information that I could. Doctors are one key source of information, but not the only source. Many patients will go on the Internet, check the newspapers and go to the library. They'll research the disease themselves to find out the state-of-the-art information. Many cancer patients find the reward of taking part in a clinical trial goes beyond improving their own health. When Wilber first mentioned the fact that he wanted to participate in this trial, I thought it was a good idea. But if you don't volunteer to help to advance medicine, we'll be at a standstill. By volunteering, you're helping not only yourself, but you're helping many others. I think I'm very, very fortunate to have a doctor that I have. He was a young, aggressive doctor. I mean, he was a doctor who believed that you looked at the new technologies in dealing with cancer. We wanted the latest medication, the latest procedures, the latest information that we could get. He just wanted to get well, and that was the main thing. And if this was going to help him, this is what we would have done, you know. Choosing to participate in a clinical trial is a big decision. The process itself can take great strength and not everyone benefits, but many do. I feel support for people who are coming after us, and that's why I'm here today, to try to help. And I would highly recommend to anybody who's offered a chance to participate in a clinical trial. You're helping others, and you're helping yourself. The key to remember is it's bad when you're there, but when you're finished, there's a real sense of accomplishment and that you've done all that you can possibly do to battle the disease. I hope more people participate in trials so that we can move knowledge in the field forward faster so we can deliver the new treatments that are coming along. This is going to become more and more important in the upcoming decade. In fact, it'll be important to everyone, at every age and in every place, because cancer touches all of us, and cancer clinical trials benefit all of us. Basically, there are two reasons why I participated in clinical trials. One is entirely selfish, because I may benefit from them. The other is that the treatments I've received that have kept me alive this long, someone had to do the clinical trials to get those going, and I have benefited from them. So if I can push the baton along the line a little bit, I'm going to do it. Fifteen years ago when I was diagnosed with ovarian cancer, I was presented with the idea of joining a clinical trial. Because I was not given all of the information about a clinical trial, what it entailed, and I was there by myself when the question was posed to me, I decided not to join the clinical trial based on a lack of information. How many times can you do something that's helpful to you, but unselfish to other people, too? How can you find out cures without going through this process? Somebody has to do it, and I'm willing to do it. For more information about clinical trials, or to find a trial you may be eligible for, call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER, or visit them on the web at www.cancer.gov. Thank you.