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General Information About Clinical Trials: What, How & Why?
Research studies conducted with subjects are called clinical trials. This information is for you, your family and friends, to explain what clinical trials are and to help you make a decision about entering a trial. This information is meant to supplement what The Center for Health Behavior Research (CHBR) staff tells you. It provides answers to questions asked most often about clinical trials.
We hope this information will help to explain how clinical studies are designed and carried out. You may decide not to take part in trial. The decision to enter a clinical trial is always up to you.
If you are interested in participating in an upcoming clinical trial, please complete the following Subject Interest Questionnaire or call 301-405-0128 and leave a message. Someone from our office will contact you for further information.
A clinical trial is a study conducted with subjects usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to treat various medical conditions. The search for effective treatments begins with basic research in laboratory studies. The best results of that research are tried in studies involving subjects, hopefully leading to findings that may help many people.
Before a new treatment is tried with subjects, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed, and, as much as possible, shows how to use them safely and effectively. But this early research cannot predict exactly how a new treatment will work with subjects. With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work.
Standard treatments, the ones now being used, are often the basis for building new, hopefully better treatments. Many new treatments are designed based on what has worked in the past, in efforts to improve on this.
Only subjects who wish to, actually take part in a clinical trial. You may be interested in or asked to enter a trial. Learn as much as you can about the trial, before you make up your mind.
How Are Clinical Trials Conducted?
The investigators who conduct a clinical trial follow a carefully designed treatment plan called a "protocol." This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of subjects as well as to answer research questions.
Some clinical trials test one research treatment in one group of subjects. Other trials compare two or more treatments in separate groups of subjects who are similar in certain ways, such as the extent of their dependence on nicotine. This way, the treatment groups are alike and the results from each can validly be compared.
One of the groups may receive placebo (containing no medication) treatment so the new treatments can be directly compared to it. The group receiving the standard treatment is called the "control" group. The control group is followed as often and carefully as the "treatment" group.
One of the ways to prevent the bias of a subject or doctor from influencing study results is "randomization." This means the subject is selected by chance to be in one group or another. Most clinical trial studies are "double-blind" meaning that neither the subject nor the investigator knows which treatment the patient is receiving.
Knowledge gained from research studies with subjects has been essential to overall progress. Such studies have led to diverse and effective treatments for assisting individuals with various medical conditions.
Why Are Clinical Trials Important?
Advances in medicine and science are the results of new ideas and approaches developed through research. New treatments must be proven to be safe and effective in scientific studies with a certain number of subjects before they can be made widely available. Through clinical trials, researchers learn which approaches are most effective. This is the best way to test a new treatment. A number of standard treatments were first shown to be effective in clinical trials. These help us find new and better treatments.
Why Would Someone Be Interested In A Clinical Trial?
People take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. Often they want to contribute to a research effort that may help others. Based on what researchers learn from laboratory studies, and sometimes earlier clinical studies and standard treatments as well, they design a trial to see if a new treatment will improve on current treatments. The hope is that it will. Often researchers use standard treatments as the building blocks to try to design better treatments.
Many trials have turned out to be better than standard treatments; others have either been not as good as or no better than the treatments already being used. Although there is always a chance that a new treatment will be disappointing, the researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments. Subjects in a clinical trial are among the first to receive new research treatments before they are widely available. How a treatment will work for a subject in a trial can't be known ahead of time. Even standard treatments, although effective for many individuals, do not carry sure benefits for everyone. Subjects should choose whether to take part in a study, only after they understand both the possible risks and benefits.
Subjects who take part in clinical trials that do prove to be better treatments, have the first chance to benefit from them. All subjects in clinical trials are carefully monitored during a trial and are followed up afterwards. They become part of a network of clinical trials carried out around the country. In this network, physicians, investigators and researchers pool their ideas and experience to design and monitor clinical studies. They share their knowledge from many specialties. Subjects in these studies receive the benefit of their expertise. At research centers, subjects receive care from a special research team.
Participation In Clinical Trials: What You Should Know
Are There Risks Or Side Effects In Clinical Trials?
Yes. The treatments used in clinical trials can cause side effects and risks depending on the type of treatment and the individual. Side effects vary from person to person.
Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what they might be. For this reason, trials can carry unknown dangers and side effects as well as hoped for benefits. Subjects need to know what is involved in a study, what side effects may be expected and, as much as possible, what "unknowns" or uncertainties they may be facing.
You will be told about the treatments being tested and will be given a form to read that discusses the risks and hoped for benefits. If you agree to take part, you will be asked to sign a form, called the informed consent form. Before you sign, be sure you understand what risks you face. Ask the staff of The Center for Health Behavior Research to explain any parts of the form or the trial that are not clear. If you do not want to be in the trial, you may refuse. Even if you sign the form, you are free to leave the trial at any time. However, you are requested to complete the necessary procedures for discontinuation.
If You're Thinking of Entering A Clinical Trial, Are You Eligible?
Every clinical trial is designed to answer a set of research questions. If you fit the guidelines for a trial, you may be eligible to take part.
This is a big question. Finding answers and making decisions are often hard for subjects. Deciding what treatment to use can be overwhelming. It is important to discuss your options with experts. Ask questions about the problems you are facing. If you understand what is going on, you can work more effectively toward your treatment.
Take time to ask questions and to discuss what you want to know. It may help if you write questions down ahead of time. No question is foolish. Learn what is available to you. Discover your choices, each individual is different. You are an individual with individual needs, and your health is important.
As you decide about treatment, whether it is in a clinical trial, remember that you are not alone. There are many people to help you: counselors, your family, physician, and friends. Although it is YOUR decision, they can help you think about it and decided what is best for you.
What Are Important Questions To Ask About A Clinical Trial?
If you are thinking about taking part in a clinical trial, here are some important questions to ask:
Informed consent, a key part of a good clinical trial, is required in studies that are federally regulated or funded as well as by many state laws. Informed consent means that as a subject, you are given information so you can understand what is involved in a trial, including its potential benefits and risks, and then decide freely to take part in it or not. The staff of The Center for Health Behavior Research explains the nature of the treatment. You are given an Informed Consent form to read and consider carefully. Ask any questions you may have; then if you agree to take part, sign the form. You may also refuse; however, you will be unable to participate in the clinical trial.
Informed consent is an ongoing process. You will continue to receive any new information about your treatment that may affect your willingness to stay in the trial. Signing a consent form does not bind you to the study. You can still leave at any time; however you are requested to complete the necessary procedures upon discontinuation.
What Is It Like To Be A Patient In A Clinical Trial?
For some people, myths and fears of "experimentation" or of being
a "Guinea pig" come with the idea of clinical trials. And, surely,
there are fears of the unknown. Understanding what is involved can ease some
of your anxieties. Subjects in a clinical trial, for example, receive their
care in the same places that standard treatments are given-at cancer centers,
clinics, or research centers.
If you join a research study, you will be watched closely and data on your case
will be carefully recorded. You may be required to complete daily diaries and
attend weekly appointments. You may also be asked to complete questionnaires
and provide information at these visits. (This allows the investigator to follow
your progress as well as to collect study data.) Although this can be inconvenient,
the information will assure an extra ounce of observation along the way. During
the course of a study, if it is clear that a treatment is not in your best interest,
you will be removed from the study and you can discuss other options.
Can You Leave A Trial At Any Time?
Yes. Just as you can refuse to join a study, you may leave a study at any time. Your rights as an individual do not change because you are a subject in a clinical trial. You may choose to take part or not, and you can always change your mind later, even after you enter a trial. However, you are requested to complete the necessary discontinuation procedures.
You may also refuse to take part in any aspect of the research. If you have questions at any time about any part of the study, be sure to ask the staff at The Center for Health Behavior Research. If you are not satisfied with the answers, you may consider leaving the study. If you decide to leave, it will not be held against you.
What Protection Do You Have As A Patient In A Clinical Trial?
The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research has built in safeguards to protect subjects. These safeguards include regular review of the protocol (the study plans) and the progress of each study by researchers at other places.
For example, an Institutional Review Board (IRB) must first approve clinical trials. The IRB is designed to protect subjects, and is comprised of scientists, physicians, clergy and other people from your local community. An IRB reviews a study to see that it is well designed with safeguards for subjects, and that the risks are reasonable in relation to the potential benefits.
A well-run clinical trial is carefully reviewed for medical ethics, subject
safety, and scientific merit by the research institution. Every study should
provide for monitoring the data and the safety of subjects on an ongoing basis.
As discussed earlier, informed consent is also an important process that helps
protect subjects.
After subjects join a clinical trial and it progresses, the investigator reports the results of the trial to scientific meetings, to medical journals whose articles are approved by experts, and to various government agencies.
What Can Help You Learn If A Trial Is Sound And Well Run?
Things that make a sound, well-run trial to safeguard subjects include the items discussed in the previous section. Keeping these items in mind, here are some important questions for you to ask to find out if a study is well-run:
For your own protection, be sure to get satisfactory answers to these questions before you agree to take part.
Do You Want To Participate In A Clinical Trial?
If you are interested in participating in an upcoming clinical trial, please complete the following Subject Interest Questionnaire or call 301-405-0128 and leave a message. Someone from our office will contact you for further information.
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