Helena W. Rodbard, MD, FACP, MACE
Michael A. Dempsey, MD, FACP
Board-Certified Endocrinologists
We are located at
3200 Tower Oaks Boulevard | Suite 250
Rockville, MD 20852
Commonly Asked Questions
What is a clinical trial?
A clinical trial is a research study. Clinical trials are designed to answer questions about medical therapies. A clinical trial may test new medical treatments for safety and efficacy. A trial may also be designed to compare a new medical treatment to currently available therapies. All clinical trials are voluntary and are carefully monitored by the Food and Drug Administration (FDA).
How will I understand what is involved in the trial?
You will participate in a process known as the "informed consent process" prior to study enrollment. This is a process during which you'll be provided with a detailed, written review of the clinical trial. The review will describe the duration of the trial, frequency of office visits, and types of laboratory testing. The study medication will be reviewed. Medication related benefits, and potential side effects, will be described. Once you've read the informed consent, you'll meet with Dr. Rodbard or Dr. Dempsey. They will review the informed consent form with you, and answer any questions. No study related testing will be initiated until this process has been completed to your satisfaction.
Why should I participate in a clinical trial?
People participate in clinical trials in our office for a variety of reasons. For some participants, it is the opportunity to participate in the the advancement of treatment of a disease which has impacted their life. Other people decide to participate in of one of our clinical trials so that they may intensively manage their disease and receive state-of--the art medical care.
Are there other benefits to a clinical trial?
Yes. All study related care and medical supplies will be supplied at no cost to you throughout the durations of the trial. Depending on the study, this may include comprehensive laboratory testing (HA1C, cholesterol, kidney, basic chemistries and blood counts), consultation with a registered dietitian, 24-hour continuous blood glucose monitoring and EKG's. Study related medical care is provided on-site by our board certified research center physicians, Dr.'s Rodbard and Dempsey.
How long do clinical trials last?
Our current studies range from 6 months to 5 years. The average study duration is 12 months.
How often will I be seen in your office?
The frequency of office visits varies with each study, but typical follow-up is every 3 months. During trial initiation, you may be seen more frequently. Many of the studies also include regular check-in via phone.
Are there risks in a clinical trial?
As with any medical therapy, there may be associated side effects. Any risks will be summarized in written form in the informed consent and will be reviewed with you, prior to trial participation, by your physician. Dr Rodbard and Dr. Dempsey will follow you carefully during every part of the trial.
Can I withdraw from the clinical trial once I've enrolled?
You may withdraw from the trial at any time. Your participation is always voluntary.
Who sponsors clinical trials?
Clinical trials are sponsored by a variety of organizations including the National Institute of Health (NIH), pharmaceutical companies, and hospitals.
What are placebos and control groups?
Placebos are inactive treatments that have no clinical benefit. Subjects in some clinical trials may be given placebo treatment to compare with the medication being studied. You will be informed of the possibility of a placebo before trial enrollment. A control group is comprised of subjects receiving a treatment that a trial medication is being compared with. Subjects in a control group may be given standard therapy or a placebo.
Will my personal physician be informed of my participation?
Yes. We will mail your physician notification of trial participation as soon as you have enrolled in a clinical trial. Upon your approval, we will forward laboratory test results and any diagnostic study results to your physician's office throughout the duration of the trial. If you desire, we'll send a dictated letter to your physician at the end of the clinical trial with a summary of your participation. You will of course continue to see your regular Primary Care Physician and other specialists throughout the trial.
Who will take care of me during the clinical trial?
All study related medical care and testing are performed in our office by Dr.'s Rodbard and Dempsey. This includes all physical exams, EKG's, eye exams and laboratory testing. Occasionally, our trials require sophisticated heart testing, such as an echocardiogram. Heart testing will be performed by board certified cardiologists with whom we work closely. All non-study related medical care and testing will continue to be managed by your personal physician.
What should I do if I'm interested in participating in a clinical trial?
Call our office, and ask to speak with the Study Coordinator of our Research Center. She will answer any questions you have, provide you with an overview of existing trials (please see our "Current Clinical Trial" section), and evaluate your eligibility. If you're interested, our Coordinator will schedule an evaluation in our Rockville office. Our phone number is 301-770-7373.