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What is a clinical trial?
Clinical trials are studies conducted to test the safety and efficacy of pharmaceutical compounds and medical devices prior to approval by regulatory agencies such as the Food and Drug Administration (FDA). DaVita Clinical Research (DCR) conducts these studies with participants at our headquarters in Minneapolis, Minnesota and at physicians’ offices and dialysis centers nationwide.
In general, a clinical trial measures the effects of a particular drug or medical device for regulatory approval. Some trials require participants to stay at the research unit overnight or longer, while other trials may involve only visits to a clinic site.
What are the responsibilities of a study participant?
Basically, participants follow the instructions of the study protocol. For example, you may be asked to refrain from caffeine or alcohol prior to or during the study. You may be asked to take the medication and provide blood and urine samples at regular intervals. Participants are required to attend all study appointments and to keep in contact with the study physician or coordinator.
Why should I participate in clinical research?
Study participants take pride in the fact that they are helping others by improving drug and treatment options for current and future generations. In addition, participants receive free medical tests and exams and are compensated for their participation time at the conclusion of the study.
How can I be sure the study is safe?
New formulations are not studied in humans until they have been evaluated and approved in the laboratory. All human studies at DaVita Clinical Research are reviewed by a committee called an Institutional Review Board (IRB). The IRB reviews the specifics of the study to ensure patient safety. DaVita Clinical Research studies each study protocol before agreeing to conduct the study and has medical personal assigned oversight for each study to ensure the safety of the trial and assure the safety the study participant.
What is informed consent?
DaVita Clinical Research staff will explain the study step-by-step to the participants and assess the potential risks and benefits. Participants are urged to have any questions fully answered at this time and to understand the study and procedures before agreeing to participate. Studies are completely described on a consent form, which participants are asked to read and sign, granting their informed consent.
How do I participate?
Click here to go to the enrollment form. Complete and submit this form, and you will be contacted by a DCR representative who will inform you when appropriate study opportunities are available.
