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What is a clinical research study?
A clinical trial is a research study conducted to determine whether new treatments, or variants of current treatments, are both safe and effective. Most studies compare one drug to another or to a placebo to evaluate which works better.
Who sponsors/monitors clinical trials?
Our clinical trials are sponsored and monitored by government agencies such as the Federal Food and Drug Administration or the National Institutes of Health and pharmaceutical companies. Our sponsors provide us with a study protocol, or guidelines, that we follow in order to ensure safe and accurate results.
What are the different types of studies?
There are four phases of medication testing: Phase I studies evaluate a drug’s safety. These often utilize young healthy people and are conducted in a hospital or similar facility. Phase II studies evaluate the medication to determine if it is likely to be effective. Phase III studies evaluate risk versus benefit of a drug. Phase IV studies evaluate other parameters such as long-term effectiveness, whether it is better than other available drugs and cost-effectiveness. Information about the phase of testing will help you know how much information is available about the drug. Most studies conducted by the UW Osteoporosis Clinical Research Program are phase III or IV.
What is my role in the research?
All trials involve working with a research team of physicians and research coordinators. We ask that you are willing and able to follow study instructions such as taking medication as directed and keeping scheduled appointments. The information generated, such as the data we obtain from bone density and blood tests, serves as a guide to the FDA’s decision about whether a drug should be approved, how the doses should be given, etc.
How much time is required of me?
Studies vary in length from one visit to several months to even years. There is a wide range of time commitments that vary with each individual study; our coordinators are willing to work around a volunteer’s schedule whenever possible.
What are the benefits of participating in a study?
By participating in a study you will be able to learn about your bone health. Your involvement in our research may help lead to better medications for you and others. You will have the opportunity to see specialists in osteoporosis and other bone diseases. The examinations, evaluations and study medications are provided to you at no charge. You may receive financial compensation for your time and effort. The amount of compensation varies with each study. Participating in a study is an opportunity for you to make a difference in the lifetime management and care of a disease that you and many others live with.
What are the potential risks associated with clinical trials?
The further a drug is in the testing process the more we know about it and its possible risks. Potential side effects differ between study medications. Before you are allowed to participate in a study, you will be advised of known possible side effects. In fact, some people who participate in our studies feel better informed of the side effects involved with prescription medication than the average person does.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before you decide to participate. If you are considering joining a clinical trial the research staff will give you an informed consent document that includes details about the study. They will discuss the study with you and answer any questions that you may have. It is important that you understand the study before enrolling. No study procedures will ever occur prior to informed consent being obtained.
Can I leave a trial after it has begun?
Yes. Participating in a research study is entirely voluntary and you may withdraw at any time for any reason.
What is a protocol?
All clinical trials are based on a set of guidelines called a protocol. A protocol describes the qualifications participants must meet to take part in the study; such as, the schedule of tests, procedures, medications, and dosages and the length of the study.
What is a placebo?
A placebo is an inactive substance that has no medicinal value. It is designed to look and feel exactly like the drug to which it is being compared. It can be a pill, a solution, or take any other form. In clinical trials, new treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies the participants in the control group will receive a placebo instead of an active drug or treatment.
What is a control group?
A control group is the standard by which experimental observations are evaluated. Often in clinical trials one group of patients will be given an investigational drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. The effect of the investigational treatment is then compared with the control group to determine the treatment’s overall effectiveness.
What is a blinded study?
A blinded study is one in which participants do not know whether they are in the experimental or control group. Those in the experimental group receive the medications being tested, while those in the control group receive a standard treatment or no treatment. If both the staff and the participants do not know which participants are receiving the experimental treatment and which participants belong to the control group then the study is called a double-blind study.