Register to Volunteer
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A clinical trial is a carefully designed research study that is done with people like you who volunteer to receive investigational treatments under the close supervision of a physician, and research professionals. Many proposed treatments make theoretical sense, or appear to be effective when tested in the laboratory or in small numbers of patients. However some, when tested in large numbers of patients, might prove ineffective or have unexpected side effects. But a number of investigational medications do prove positive. Therefore, rigorous trials in large numbers of patients are necessary for a medication to be approved by the Food and Drug Administration.
Participation is open to everyone; however, all clinical trials have requirements about who can participate. Some clinical trials seek participants with a specific illness or condition that will be studied in the trial. The inclusion and exclusion criteria are used to identify appropriate participants to ensure the researchers are able to learn what is needed for the study and to encourage participant safety. Before a person can join a clinical trial, they must qualify for the study. The guidelines that allow volunteers to participate in a study are called “inclusion criteria” and the guidelines that do not allow a person to participate are called “exclusion criteria”. These criteria can include things like, age, the type and stage of a disease, previous treatment history and other medical conditions.
People volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not exist presently. You may join a clinical trial hoping to get improved medical care. Or you may not have health insurance, and clinical trials are a way to get study-related medical care. You should ask your physician and your research center staff any questions before you volunteer.
First, you are educated about the drug being tested, with comprehensive review of the procedures performed, descriptions of the potential benefits and side effects, as well as answering any questions about the study, disease or disorder.
After review of the consent form (which contains the details of the study), and you decide to participate, the screening process begins.
During the screening period, information is gathered and tests are performed to determine whether you are eligible to participate. If eligible, then you are then enrolled into the study to receive the investigational product.
Once entered into a clinical trial, you are typically randomized (randomly selected) to receive the study medication. The study medication (per the study) may be active drug with one or multiple dosages, or a placebo (a substance that looks exactly like the active study medication but has no medicinal effects). The consent will cover the treatment arms.
You, the research staff and your doctors will not know which drug or dosage you are actually receiving. But in cases of emergency, it can be obtained.
Follow up visits will be listed in the consent along with the frequency of the visits. The follow up visits are conducted to monitor your progress, assess side effects, and will include testing and/or questionnaires etc to evaluate your health status during the trial up to the final study visit.
A research study can last for a few weeks to as many as 2 years. Each study had different requirements and be reviewed with you during the consent visit.
Participating in a clinical trial might provide more effective treatment for your disease, or there might be no benefit at all. Participating may also help people in the future with the same disease. Study medication is provided at no cost to the participant, as well as study related medical testing and close medical follow-up. Some clinical trials provide funds to reimburse for time and travel. The study drug might cause side effects, many of which can be anticipated. However, unanticipated side effects can also occur, some of which could be severe or life threatening, Known side effects will be listed in the consent form. Careful follow-up while taking a new medication is standard, and each clinical trial is carefully monitored for the appearance of new side effects. Event reports are immediately communicated to the study doctors. The study doctor or a member of the research team will inform participants of any new information or changes in the study that might affect their health or willingness to stay in the study.
You can withdraw from any study at any time for any reason. If you do so, the research coordinator might ask you to complete a discontinuation visit and stay in touch with you for a period of time to ensure that no unanticipated side effects occur. It is important to remember that your participation is entirely voluntary and it will in no way, affect your medical care at this or any facility.