Enhancing Patient Care through Clinical Research
Family Health Care of Ellensburg is committed to improving the lives of their patients by supporting innovative research. This includes participation in clinical trials for emerging medications and ongoing research studies in many areas.
- What Is A Clinical Trial?
- Are Clinical Trials Safe?
- Why Volunteer?
- Who Can Participate In Clinical Trials?
- Who Should I Contact For Additional Information?
Clinical trials are research studies, conducted in people who volunteer to participate. They are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.
There are different kinds of clinical trials, including those to study prevention options, new treatments or new ways to use existing treatments, new screening and diagnostic techniques, and options for improving the quality of life for people who have serious medical conditions. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.
Human testing of experimental drugs and device is typically conducted in four phases. The FDA must review the results of each phase before the next phase of testing can begin.
Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100). The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted.
Phase II studies test a drug or device to determine how effective it is. This second phase of testing can involve several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug.
Phase III studies involve randomized and blinded testing in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, and the benefits and the range of possible adverse reactions.
Phase IV studies are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.
The FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial. The federal government also has regulations and guidelines for clinical research to protect participants from unreasonable risks.
Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in research studies involving new medical treatments.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an "informed consent" document before joining the study indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial.
Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:
- Become actively involved in their health care.
- Potentially gain access to new investigational treatments that are not available to the general public.
- Help others by contributing to medical research.
The protocol for each clinical trial specifies who can participate in the study. Some trials enroll healthy people while others only allow those with specified illnesses to participate.
Family Health Care of Ellensburg is currently enrolling patients in studies who meet the following criteria:
- Adults, 65 years of age and older, who are beginning warfarin therapy.
- Adolescents and adults, 12 years of age or older, who have been diagnosed with asthma.
- Healthy 12 to 15 month old children.
If you desire further information or have questions, please contact our Clinical Research Coordinator:
Diane Bowman, CMA, CCRC at 509-962-6348.