A clinical trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Participants may receive study-related exams, lab work, EKGs, bone density scans, and study medication at no cost.
Dallas Diabetes and Endocrine Center participates in trials that study treatments for Diabetes, Diabetic Neuropathy, Nephropathy, High Cholesterol, and Obesity.
An investigational medication is a drug that is not yet approved by the Food and Drug Administration (FDA), but can be tested in research studies.
A placebo is an inactive substance designed to resemble the drug tested. It is used as a control to rule out any psychological effects testing may present.
As with all drugs, there may be some risk of side effects. However, if you are accepted in a study, we will thoroughly discuss this information in detail with you during what is called the informed consent process.
If you are selected to participate, you will receive close medical attention and monitoring by medical specialists. According to the specific study, you may receive study-related physical exams, lab work, EKG’s, blood glucose monitoring supplies, and study medication at no cost.
Tell your doctor that you may become a volunteer patient for a research study. Your doctor also needs to know that for the duration of the study, the doctors at the study site will be evaluating you. You will be provided with copies of your lab results to give to your physician. If you wish, a clinical investigator will be happy to discuss the treatment with your doctor.
Your participation in any research study is entirely voluntary. If at any time throughout the study you decide that you no longer want to participate, you have the option of withdrawing from the study. You just need to let us know, and we ask that you come in for one final visit to make sure you are doing OK.
Please let us assure you that any information you provide will be kept confidential. Unless required by law, only the study doctor and staff, the study sponsor and its authorized agents, the FDA, government agencies in other countries where the study may be considered for approval and the institutional review board will have access to confidential information which identifies you by name. Because of the need for these parties to have access to this information, absolute confidentiality cannot be guaranteed. You will not, however, be identified by name in any reports or publications.
At your first visit, a staff member will visit with you to discuss your healthcare needs so we can help you in reaching your goals. Your medical history will be reviewed, so it is helpful if you can bring a list of your current medications. You may have vital signs taken, lab work, and visit with our physcian assistant during your initial visit.