Kidney Care Clinical Trials and Research

Research

Clinical trials (also called research studies) are conducted to test safety and effectiveness of new medications and new uses for existing medications. The physicians of Nephrology Inc. value the importance of clinical research and the discovery of new medications to advance the knowledge of medical science.

In 2006 in a continuing effort to offer our patients superior care Nephrology Inc., established a research program. Participating in research makes it possible for us to offer our patients medical care that may not be available to the general public, and it ensures that we remain on the cutting edge of medical treatment and technology.


What is a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. The physicians and staff at Nephrology, Inc., run these trials according to strict rules set by the Food and Drug Administration (FDA), to ensure that the people who agree to be in the studies are treated as safely as possible.



FAQ's about Clinical Trials

What are the benefits of participating in a clinical trial?


What are the risks of participating in a clinical trial?


Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. These guidelines (also called inclusion/exclusion criteria) are based on multiple characteristics such as type and stage of disease, current medical condition, medical history, age. These guidelines are used to identify appropriate participants and keep them safe; it also ensures that the researchers will be able to answer the questions they plan to study.


What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. Your doctor or the research nurse will explain the details of the trial to you, and then a member of the research team will provide you with an informed consent document that includes specific details about the trial. Before you can be in the study, you must sign the informed consent form, showing that you have been given the study information and understand it. Informed consent is not a contract and the participant may withdraw from the trial at any time.


What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. All Nephrology Inc. physicians have been trained, and have agreed to participate in all clinical research studies being offered at Nephrology, Inc., therefore our research participants will remain under the care of their physician during the course of the study. The research team will check the health of the participant at the beginning of the trial, give special instructions for participating in the trial, monitor the participant carefully during the trial and arrange follow up with the participant at the end of the trial.


What are the phases of clinical trials?
Clinical trails are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
Most trials that are conducted at Nephrology, Inc., will fall into the following categories;

Are Clinical trials safe?
The government, pharmaceutical and biotechnology industries have standard guidelines that all clinical research sites must follow in order to conduct clinical trials. Audits are performed on a regular basis to make sure the guidelines are being followed. In addition to these safeguards, every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.


What questions should patients ask before participating in a clinical trial?
When considering participating in a clinical trial you should know as much as possible about the trial and feel comfortable asking the members of the health care/research team questions about it. The following questions might be helpful for the participant. Some of the answers to these questions are found in the informed consent document.





Websites

Where to find more information about clinical trials:
http://www.nih.gov
http://www.ciscrp.org
http://www.clinicaltrials.gov
http://www.centerwatch.com




Current Studies/Contact Information

Clinical trial currently available at Nephrology, Inc.



For information about the current studies please contact:

Cindy Nagy RN, CCRP
Research Coordinator
Nephrology, Inc.
(574) 273-6787 ext. 1211