Clinical Trials at Grand View
At Grand View Hospital, medical and surgical physicians have gained access to a national network of clinical studies. This enhances their expertise and provides additional treatment options to patients, including some of the most promising clinical trials available today. We serve our community by giving patients access to cutting edge treatments without having to travel far from home. Because of our dedication to clinical research and affiliation with various national organizations, we are able to provide patients in our community with the opportunity to participate in the same research studies being offered at large university hospitals throughout the country.
What is a Clinical Trial?
A clinical trial is a research study designed to answer specific health questions related to the development, production and evaluation of the effectiveness of new treatments and therapies for diseases. Clinical trials rely on human volunteers to carefully and safely evaluate new treatment options and ways to improve health in a controlled setting. Clinical trials test the benefits of experimental treatments, new medications, combinations of existing drugs and new ways of using known therapies. These tests use the most advanced drug therapies available. If a trial proves successful, the treatment may become a standard practice to improve health. Each clinical trial has different guidelines for who can participate, and follows specific protocols.
What are Clinical Trial Protocols?
Clinical trial protocols are the guidelines that must be followed during the course of any study. For patient safety, each protocol must be approved by the organization that sponsors the study and the Institutional Review Board (IRB) at the Hospital. The IRB, which includes community members, clergy and health professionals, reviews the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.
Phases of a Clinical Trial
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In 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, how it should be administered (orally, intravenously, or by injection) and how often, determine a safe dosage range, and identify side effects.
In Phase II Trials, the experimental study drug or treatment is given to a larger group of people (100-300) to provide preliminary information about how well the new drug works and generates more information about its safety and benefits.
In Phase III Trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV Trials, continued evaluation that takes place after FDA approval, when the drug is already on the market and available for general use.
Who can participate in a trial?
Each protocol in a trial defines specific characteristics, called eligibility criteria that participants should have to participate in the study. Characteristics may include type of disease and its stage, as well as the participant's age and general health.
Eligibility criteria help assure that the study results answer the research question and identify who will benefit in the future from the approach being studied.
What clinical trials are available at Grand View?
http://www.clinicaltrial.gov/ct/info/resources
Disclaimer: The following descriptions are very clinical. We advise you to contact the study coordinator to arrange further explanation. |
