What is a clinical trial?A clinical trial is a research study designed to answer specific questions about new therapies or new ways of using known treatments. Clinical trials are conducted to determine whether new drugs or treatments are both safe and effective. Clinical trials must meet the stringent standards set by the U.S. Food and Drug Administration (FDA) prior to being introduced to the public. Researchers compare trial results in order to obtain FDA approval for marketing of the drug to physicians and consumers. Carefully conducted clinical trials are the safest and most effective way to find treatments that work. All clinical studies must meet stringent Clinical Practice Guidelines and must meet the Code of Federal Regulations established by the FDA. Participating in a clinical trialAs a participant in a study, you become an active partner along with your research team of professionals. This will help you learn more about your disease and will help to develop more effective treatments. Clinical trials supply you with free study medications during the trial period, free medical care and monitoring, and in many cases reimbursement for travel expenses and/or a payment for your participation. With your consent, your physicians will be kept well informed of your progress during the clinical trial. Your doctor may actually be the physician in charge of the study. If you agree to participate in a clinical trial, the process will depend on the particular type of trial you participate in. You will meet with our team of doctors and nurses, and in some cases social workers and other health care professionals. This research team will check your health prior to the start of the trial and will continue monitoring you carefully during the trial. You will be given explicit instructions, and will be required to follow the protocol. You will receive one-on-one patient care and will meet with the same team of physicians and nurses each time you visit Clinical Partners. This ensures continuity of care, and allows us to develop a personal and individual study protocol for all participants. There are very strict guidelines to protect clinical trial participants. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure that 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 a clinical trial is ethical and that a participant’s rights are protected. Our site can utilize central or local IRBs. Clinical Partners areas of expertise include:
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