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About Clinical Research
Clinical research is essential to new drug development. Through research, new drugs are tested for effectiveness and safety. The final phases of clinical research, involving patients with chronic or acute illness, follow years of research in the laboratory as well as testing of the drug in people who have no illnesses. Only after all phases of research are complete can the Food and Drug Administration approve drugs for use by the general public Before a patient learns that a new drug is available for their condition, many patients have taken the drug on an investigational basis. Patients who participate in clinical research help in the development of new treatments which help people to live longer and feel better. There are many reasons why
patients decide to participate in research. Some patients are interested in
the advancement of science or want to be part of something that may help
others. Some participants value the no-cost care that research involves, such
as study medication and visits with staff nurses and physicians. Some studies
involve more frequent visits than standard insurance would allow, and this
provides patients with the benefits of additional monitoring and education.
Many laws and safeguards are
in place to protect the rights and safety of patients who volunteer for
clinical research. Clinical
research trials are carefully designed to protect and monitor patients who
receive investigational drugs. Before
the first participant enrolls, every trial is reviewed by the FDA and approved
by an Institutional Review Board. The
role of the IRB is to ensure that patient rights are protected; an important
part of IRB approval is to review the informed consent for the trial to ensure
that it lists all information that a patient needs to make a decision about
participating. ABOUT
CLINICAL RESEARCH AT THE HEART AND VASCULAR CLINIC OF NORTHERN COLORADO In an effort to provide state-of-the-art care to patients, the physicians of the Heart and Vascular Clinic actively support clinical research. Participation in clinical research is always voluntary, and declining a research study that has been offered to you will never impact any other aspect of your care in the clinic. The first priority of the cardiologists and staff of the Heart and Vascular Clinic is the safety and well-being of our patients. Prior to enrolling a patient in a trial, an extensive review of the patient’s records and situation is completed, and patients have an opportunity to meet with their cardiologist to discuss the trial. The cardiologists of the Heart and Vascular Clinic are closely involved in the care of patients who participate in research trials. If at any time, you or your cardiologist believe that participating in a trial is not in your best interest, you can be withdrawn from the trial. The Heart and Vascular Clinic has been the site of more than 20 clinical trials. The Research Department includes three Clinical Research Coordinators, who are Registered Nurses with cardiology experience and whose time is dedicated to research. The eleven cardiologists of the Heart and Vascular Clinic are involved in all research trials done at the clinic. Dr. Wyatt Voyles, who has conducted clinical trials for more than twenty years, is the Director of Research. If you are
interested in participating in or learning more about clinical research,
please ask your cardiologist or contact the Research Department at (970)
221-1000. |
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