 The Hope Heart Institute's Clinical Research Program includes more than two-dozen well respected physicians around Western Washington. The doctors in the program conduct clinical studies in their private practices. Meet our Doctors.
Clinical trials involve patients who volunteer to participate in the research program. Clinical trials are the final step in a long process that could lead to new devices, medications or methods of treatment to improve the treatment of heart disease. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
At any given time there are more than a dozen clinical trials underway. Click here to read more about current Hope Heart clinical trials.
Download Hope clinical research brochure.
It can take more than a decade for scientific breakthroughs in the lab to become available to patients. Once treatments come out of the lab, they go through a series of clinical trials. Here is how it works:
Phase I:
Involves a small number of people and is the first study on humans. The goal is to see if the treatment is safe, if it has harmful side effects, and how it is best administered. If the results are positive, researchers move on to Phase II.
Phase II:
Is designed to measure the new therapy's safety and effectiveness in fighting disease. Again, only a small number of participants take part in these studies. If the study shows a benefit to patients, the treatment moves on to Phase III.
Phase III:
Examines how the new therapy compares to standard treatments, the "benchmark" for measuring and evaluating new and improved possibilities in medical treatments. These trials involved hundreds of participants at different hospitals, cooperative groups and research centers.
Phase IV & V:
Examines a therapy once it has been FDA approved and the therapy is available to the public. Usually several hundred to several thousand participants take part in these studies. They assist in further evaluating the long-term safety and effectiveness of a new treatment.
Other Types of Clinical Studies.
There are also supportive care or quality of life studies that are designed to improve comfort and quality of life for people who have been diagnosed with a disease. These types of trials may study the impact of treatment or services on patients, their family members, or the health care providers caring for these individuals.
In addition, there are clinical trials which include the collection of tissue or blood specimens that will be used for testing new technologies or therapies.
In all of these trials the objective is furthering the understanding a disease and its impact on patients and their families.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What are the benefits and risks of participating in a clinical trial?
Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
Risks
There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
Why are Clinical Trials Important?
Clinical trials contribute to knowledge of and progress toward treating disease. Trials are designed to help determine the safety and effectiveness of new treatments, and represent new possibilities for patients facing a medical illness. They offer promise for enhanced therapies and inspire physicians to seek the best treatment options for their patients. Many of today's most effective treatments in healthcare are based on previous study results. Because of progress made through clinical trials, many people are living longer.
Clinical trials are a critical part of the research process. Clinical trials translate basic scientific research results into better ways to prevent, diagnose, or treat disease. Clinical trials are the final step in a long research process.
The more people who participate in clinical trials, the faster critical research questions can be answered that will lead to better treatment and prevention options for all types of diseases. We will never know the true effectiveness of a treatment or a way to prevent specific diseases such as cancer, heart disease, or stroke unless more people are involved in clinical trials.
In the past, clinical trials were sometimes seen as the last resort for patients who had no other treatment choices. This is not true; there are many clinical trials for prevention of certain disease processes. We must also keep in mind clinical trials may provide us with the newest way to treat a disease that is not available any other way.
Once a new drug or intervention is proven safe and effective in a clinical trial, it may become the new standard of practice. Everything we can tell people about treatment options for their medical ailments today is based on the results of clinical trials. Members of the interested public can help speed up the research process.
It takes 14 years, on average, for an experimental drug to travel from laboratory to U.S. consumers. Often the longest part of the process is finding people to participate in each trial phase. With increased public awareness about clinical trials, more people may be willing to participate, and more professionals may refer people into appropriate trials. This awareness ultimately reduces the time it takes for researchers to enroll participants in trials and complete them-and speeds the movement of new drugs or treatments into standard care.
For more information on Hope Heart Clinical Research programs email: clinicalresearch@hopeheart.org
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September 19, 2008 |
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November 7, 2008 |
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