Participating in Cancer Clinical Trials: What You Need to Know



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 realize 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 you when your doctor recommends that you participate in a clinical trial you are being offered the ability to go one step further than a standard tool to do a little bit more and even though it's not proven it may benefit 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 the 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 have asked for 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 are safe and effective for people for the patient 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 the researchers use them to directly compare new treatments with standard treatments this results in new standards for here 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 as 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 the 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 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 trials 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're 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 that's 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 the 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 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 the 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

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