DNPC engages in a variety of clinical research activities through its Research Division, under the direction of Geoffrey A. Block, M.D., and its Transplant Research Division, under the direction of Bradley A. Marder, M.D. Recent studies have evaluated the use of the calcimimetic medication, cinacalcet (Sensipar) in dialysis patients with secondary hyperparathyroidism; and cardiac calcification in dialysis patients taking either calcium carbonate or sevalemer (Renagel) as a phosphate binder.
What is a Clinical Trial?
A clinical trial is a research study conducted in human volunteers. The goal of a clinical trial is to answer important medical and scientific questions with the hope of finding better ways to treat different diseases such as kidney disease. Clinical trials also evaluate the safety and effectiveness of new drugs or combinations of different drugs.
Why Participate in a Clinical Trial?
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.
How do Clinical Trials Work?
All clinical trials have guidelines about who can participate. These guidelines help to produce reliable results. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in that clinical trial, while others need healthy participants.
Clinical trials are conducted in different “phases”. The trials at each phase have a different purpose and help scientists answer different questions. Generally, clinical trials go through 4 phases of studies.
- Phase I trials: researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II trials: the experimental study drug or treatment is given to a larger group of people (100-300) who are afflicted with the disease or condition for which the drug was developed to see if it is effective and to further evaluate its safety.
- Phase III: the third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients.
- Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
- Phase IV: after a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
One of the most important parts of a clinical trial is called “informed consent”. Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. Before your participation in a clinical trial begins, the study doctor will explain the details of the study. These details are contained in an “informed consent form”. You will be asked to sign the informed consent form before you participate in a study. Informed consent is not a contract. Participants can withdraw from a study at any time.
The Patient Always Comes First:
Throughout the clinical trial, your needs as a patient come first. If there is no improvement in your condition or the treatment causes intolerable side effects, you and your physician may decide to discontinue the study and proceed with other available treatment options.
How can I find out more information about clinical trials?
You can visit the National Institutes of Health Website at: http://clinicaltrials.gov
You can also contact the study research staff to ask questions about specific trials.
Denver Nephrology Research Division
130 Rampart Way, Suite 300B
Denver CO 80230
Phone: (303) 364-4775
Fax: (303) 364-4776
mpersky@denverneph.net
Denver Nephrology Transplant Research
1601 E. 19th Avenue, Suite 4300
Denver, CO 80218
Phone: (303) 861-4845
Fax: (303) 861-4842