Frequently Asked Questions
Researchers, doctors, and other health professionals conduct research studies according to strict rules set by the Food and Drug Administration (FDA). The FDA created these rules to protect clinical trial participants and to make sure they are treated as safely as possible. Research studies are also overseen by medical ethics groups to ensure that study participants are treated appropriately.
Yes. You are free to leave the trial at any time. If you do decide to leave, you should let the study team know and tell them why you are leaving the study. Early study termination procedures will be done to ensure your safe exit from the study.
Each study has its own set of criteria and its own schedule and duration. Some trials are as short as several days, others are over one year. Your research nurse will be able to tell you how long each study is, how many visits are required, and approximately how long each appointment will take.
Participation in a clinical trial is at no cost to you. No insurances are billed, no co-pays are collected. All study procedures are provided through the research program and paid for by the drug company studying the medication.
A placebo is a “blank” or “sugar pill” (although it is not made of sugar). Basically, this is a duplicate of the study medication, but contains no active substance which would affect the condition being studied. Most studies we conduct DO have a placebo. This is mandated by the FDA and helps prove effectiveness of the medication and helps determine if a health event is likely related to the study medication, or not. For example, if participants on the study medication had headaches, and it was found that similar numbers of people on placebo and active study medication had headaches occur, it would seem unlikely the real study medication was the cause of the headaches.
Often the medication under study will not be available by prescription upon completion of the trial, therefore it would be unlikely you would have access to the medication if (until) it is approved by the FDA. The research doctors may make a recommendation for your treatment, may prescribe an available medication for you to use, or may refer you to your family doctor for this discussion.
Studies are conducted at our headquarters in Miami, FL. All your study appointments will be held at the office in which you sign up for the study. Our office offers a variety of trials. Once you enroll in a study at one clinic, you will attend all appointments for that study at that particular office.
During participation in a study, the research doctors manage your care related to the condition being studied. Your normal family practitioner will manage all other aspects of your care. We do wish to be a part of your healthcare team, and will ask your permission to communicate with your family practitioner throughout your participation in the trial, if needed.
Epocrates Medical & Research Center conducts only phase II-IV studies, meaning only people who have the medical condition under study are allowed in the trials. The criteria for entry vary from study to study and can be discussed with a research nurse over the phone or an appointment can be made to review the study in detail and help determine if a person is eligible to participate.
New drugs are developed in laboratories, many tested on animals, then on healthy humans to determine side effects and appropriate doses. Another group of volunteers with the medical condition is tested using the doses found to be well tolerated. These individuals’ participation help to determine if and how effective each dose of medication is on the condition being studied. They will also help efine what the potential side effects of the medicine are. Yet another group of people with the medical condition being studied will participate in a larger trial. Again, effectiveness and side effects of the medication being tested will be detailed.
These trials are necessary to provide information to the FDA to determine if the new drug is safe enough and effective enough to be made available by prescription.
While participants are involved in clinical trials, their health and safety is monitored very closely by the study team. Each trial will have a very specific set of criteria to determine who can be allowed in the program. There are also very strict visit schedules for each trial.