A clinical trial is a research study to answer specific scientific and medical questions such as how vaccines work, if a new therapy is effective or determining new ways of using known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new drugs or treatments are safe and effective. They are also the basis of understanding how certain diseases affect humans. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.
Some trials are not researching treatments or therapies but are looking at how the immune system or other body functions perform. These types of trials are called basic science trials and will not involve taking medications.
In these trials, the researcher may ask for samples of blood or other tissue, or may look for other signs of what your body does naturally. Basic science trials determine what is causing the disease or condition. It is looking for a virus, bacteria, genetic conditions, parasites, malignancies, environmental factors or other problems. Therefore, these trials are conducted to determine what direction therapies may work in before a clinical trial of medications can be started.
Clinical trials of experimental drugs proceed through four phases:
The clinical trial process depends on the kind of trial you participate in. The team will include doctors and nurses. There may be social workers and other health care professionals involved as well. They will check your health at the beginning of the trial, give you specific instructions for participation, monitor you carefully, and stay in touch with you after the study.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work with a research team. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff.
In every clinical trial, the researcher needs to compare people with the characteristic that is being studied with a person who does not have that characteristic in order to determine what is different. Controls are important for both trials of therapies and basic science trials. The researcher will probably "match" the participants who have the condition being studied with controls by age, race and other factors. This will help to determine if these demographic characteristics have an effect on the condition and also to factor out any differences that may be caused by these characteristics.
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
The researcher will design a trial to address a specific question. Essentially, the researcher would like to know if a drug or if the body works the way he or she thinks it does, this is the hypothesis. Each test or procedure is designed to find out if the hypothesis is correct or incorrect.
The government has strict guidelines and safeguards to protect people who chose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.
As part of that protection, you will be required to sign informed consent forms. Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:
If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. You should ask the research team any questions you may have about the study and the consent forms before you make a decision. Informed consent is more than signing a form; it is a process that continues through the study. Feel free to ask the research tem questions before, during and after the study.
While participating in the study you should continue working with your primary health care provider. Most clinical trials provide short-term treatments related to a designated illness or condition, but not extended or complete primary health care. In addition, by having your health care provider work with the research team, you can ensure that your other medications or treatments will not conflict with the clinical trial protocol.
Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:
Remember that you can leave a clinical trial at any time. If you plan to stop participating, please contact the research team and let them know why you are leaving the study.