Questions About Research
The following is a list of common questions and answers about the clinical research studies conducted at The Lindner Research Center.
What should I know about Research?
• A clinical trial is a study done by researchers to test the safety and effectiveness of new investigational drugs, vaccines, devices, or procedures.
• Clinical trials may also research new treatments, new drugs or new surgical procedures.
• Clinical trials are an essential step in the process of making new drugs and devices available to patients. Research studies allow pharmaceutical and device companies and the government to determine the safety and effectiveness of new products. Clinical trials are essential for the advancement of medical science.
• Clinical trials are conducted in phases; requiring specific criteria to be achieved at each level.
• In a clinical trial by random assignment, some participants will receive the investigational treatment while others will receive a placebo or a treatment that is already approved and available. This allows the investigational treatment to be compared objectively.
• Whether you receive the investigational treatment or the placebo, all patients receive a high level of care and attention from the research team.
• Most medications and devices today have gone through a series of clinical trials in which their safety and effectiveness was proven to the FDA prior to their release.
What can I expect when I participate in a clinical trial?
• You will be asked to review and sign a consent form. This will be discussed with you to assure your understanding.
• Once enrolled in a study, you may receive a physical examination.
• Your medical history will be reviewed.
• Your safety is the number one priority in a clinical trial. Therefore, it is important that you follow study directions, keep all of your scheduled visits, and cooperate with questions regarding how you feel.
• Participants may be able to gain access to research treatment that may not otherwise be available. You may also have access to study medication or study devices, medical care and laboratory services, all at no cost.
• Your study coordinator will record any symptoms that you may experience because your input is valuable and important, forming some of the basis under which the treatment is evaluated.
• Your privacy is protected and your medical records are confidential.
• All trial data that is provided to the pharmaceutical or device companies and the FDA will not include your name or any individual participants.
• You have the right to leave the study at any time.