The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at the Clinical Center cannot be accomplished.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
Clinical studies are research studies in which real people participate as volunteers. Clinical trials are a means of developing new treatments and medications for diseases and conditions. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients.
Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared. Analyses are done at intervals during a trial, which may last years. As soon as one treatment is found to be definitely superior, the trial is stopped. In this way, the fewest number of patients receive the less beneficial treatment.
In single- or double-blind studies, the participants don't know which medicine is being used, and they can describe what happens without bias. Blind studies are designed to prevent anyone (doctors, nurses, or patients) from influencing the results. This allows scientifically accurate conclusions. In single-blind ("single-masked") studies, only the patient is not told what is being given. In a double-blind study, only the pharmacist knows; the doctors, nurses, patients, and other health care staff are not informed. If medically necessary, however, it is always possible to find out what the patient is taking.
Risks are involved in clinical research, as in routine medical care and activities of daily living. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.
Clinical trials are free of charge to all subjects participating. All study related treatments and medication are paid for by the drug company sponsoring the study. Subjects will receive financial compensation for their time. We will never ask for your insurance information as it is not needed for your participation in a clinical trial.
For studies that are testing the safety of a drug (Phase I), only very healthy individuals with no health risk factors can participate in a study. For studies that test the effectiveness of a drug to treat certain symptoms (Phase II-IV), patients are selected based upon certain health criteria. Patients will qualify if they have a certain diagnosis or risk factors that the drug is intended to treat.
There is no limit on the number of studies you can do over a period of time. However, you can only participate in one study at a time in order for there not to be interactions between investigational drugs. Most studies require there to be a one month period in between starting new studies in order for the body to wash out of any previous therapy or drug from another study.
After a volunteer completes a study, they will no longer recieve study drug free or charge. However, many drugs that are tested in clinical studies are on the market and available with a prescription that could be written by the doctor who was conducting the clinical trial. If the drug is not yet approved by the FDA then the drug is not available by prescription. Our goal, with your help, is to complete these necessary studies to allow the drug company to seek approval by the FDA.
Clinical research studies do not require insurance. All study related medication and procedures are covered by the sponsor (pharmaceutical company). We will never ask for a copy of your insurance card or information.