What should I expect from a study?
If you volunteer in a clinical trial, you will have an appointment to meet with our qualified medical professionals who will explain the purpose and procedures of the study, the potential benefits and risks of the medication and alternative treatments. The informed consent form will be thoroughly reviewed with you so you can make an informed decision regarding participating in the research study. Please take as much time as needed and we encourage you to review the study with your family, loved ones, and doctor, as needed. We will go over the study in detail and discuss the time commitment that is necessary, tell you what we expect from you as well as what to expect from us. You will be asked review the consent form privately. We will then answer any questions you may have regarding the study.
Once you decide to participate, you will be asked to sign a consent form prior to performing any study procedures and will be given a copy for your records. All information is kept confidential and is not shared with anyone other than study staff.
As part of the screening process, your medical history and current medication information will be obtained. The study physician will conduct a physical exam and other tests such as blood work, urinalysis, electrocardiogram and vital signs (blood pressure, weight, etc.), as required by the study. Other specialized tests may be ordered depending upon the condition being studied. We ask that you are truthful with the study staff so we can ensure the study is a good fit for you.
If you qualify for the study, a follow-up visit will be scheduled during which you will be given the study medication. We ask that you follow all instructions, take the medication as directed, and inform us of any changes in your health or medications. During the study, you will come in for follow-up visits where you will be asked questions regarding your health, medication compliance will be checked, and we will review your medications with you. Interim physical exams, or blood & urine tests may also be required. If everything looks good, you will be issued the next supply of medication and we will schedule your next follow-up visit based on your schedule. You can stop the study at any time. We just ask that you come in for a final visit, so we can conduct a final evaluation and collect all study related medication and diaries, etc. We are always available to answer any questions you may have as we progress through the study.
At the end of the study, a final visit is scheduled at which you will have a final physical exam, blood work & urinalysis, electrocardiogram & vital signs, as required by the study. The physician will discuss your progress as well as how you should follow-up regarding your condition.
We are confident that you will enjoy the care and respect your receive throughout the study by our medical staff. This is proven by the fact that our research patients ask us to contact them for any future studies that may be a good fit for them.