Answers about clinical trial participation give you confidence in the impact of taking part in groundbreaking medical research.
When you participate in clinical trials, you have access to the latest evidence-based treatment options and innovative technologies from leading specialty-trained experts who provide you with compassionate care while advancing medical care for generations to come.
It’s important for you to understand all aspects of participating, so you feel confident and fully informed to help you make the best decisions for your own outcomes.
When you choose to take part in a clinical trial, the care you are given is much like the care you would otherwise receive. However, there is often additional monitoring for the purpose of learning about potential side effects and benefits of the care you are receiving. Some trials simply test a study regimen (and all participants receive this same regimen). Other trials may compare a study regimen to the standard treatment. In this type of study, you are randomly assigned to receive one regimen or the other. Neither you nor your doctor can choose which one you will receive to ensure the study findings are credible. In clinical trials for drug testing, some people worry that they will not know which drug they are receiving or that they will receive a placebo, sometimes called a “sugar pill.” Placebos are never used in place of a treatment that is known to work. You will always be told before agreeing to take part if a placebo is going to be considered.
The ultimate purpose of a clinical trial is to answer a medical question. People who take part in clinical trials may need to do certain things or have certain tests done to stay in the study. Most people enrolled in clinical trials appreciate the extra attention they receive from their health care team. A 2005 study surveyed more than 1,700 people with cancer about their awareness and attitudes regarding clinical trials. Only a small portion took part in clinical trials. But most of those who did were very satisfied: 96% said they were treated with dignity and respect, 92% said they had a positive experience, and 91% would recommend that family or friends take part in a clinical trial if faced with cancer.
The most important thing is that your rights as a research participant are protected, regardless of the nature of the study or the participant group in which you may be placed. The Christ Hospital Institutional Review Board (IRB) is the body that oversees the research being performed at The Christ Hospital Health Network. The IRB assures research is conducted within established regulations and conforms to the policies and procedures the hospital developed to protect the rights and safety of research participants.
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The decision to take part in a clinical trial is a personal one. You may wish to talk to your family and loved ones, as well as members of your health care team, before deciding. As with all current standard treatments, there can be possible risks and benefits from taking part in clinical trials. We encourage you to ask questions before agreeing to participate in a study. Below are a few suggested questions from the Office of Human Research Protections of the U.S. Department of Health & Human Services that may help you get started.
Study drugs and devices may be found to be more or less effective than current standard treatments and have side effects not yet known. You will be informed of these risks as much as possible. Your health care team will give you the information you need to make the decision that is right for you.
Informed consent means you must be told the key facts about a clinical trial and have all your questions answered before deciding whether to take part. If you agree to take part, the informed consent process involves signing a form that describes the entire clinical trial, possible side effects, and potential risks and benefits. You may withdraw your decision to participate at any time for any reason.
The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Very few of the drugs/devices tested are granted a New Drug Approval or New Device Approval by the U.S. Food & Drug Administration (FDA), which allows the drug or device to be accessible by the public.
Phase I studies are primarily concerned with assessing a drug’s or device’s safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body—how it is absorbed, metabolized and excreted. A phase I study investigates side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.
Once a drug or device has been shown to be safe, it must be tested for efficacy. Phase II of testing may last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials; one group of patients will receive the experimental drug or device, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.
In a Phase III study, a drug or device is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's or device’s effectiveness, benefits and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical or device company can request FDA approval for marketing the drug or device.
Often termed “post-marketing studies” or late Phase III/Phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug or device with other drugs or devices already in the market; (2) studies are often designed to monitor a drug's or device’s long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy or device treatment relative to other traditional and new therapies or devices.
Clinical trials are continuously conducted locally and nationally. You can find a list of all clinical trials at The National Institute of Health. To participate in a clinical trial with The Christ Hospital Health Network, search the Lindner Research Center or Cancer Clinical Trials directories.