Why does Sutter do research?
What is a clinical trial?
How do clinical trials come into being?
What happens during a clinical trial?
Why would I want to participate in a clinical trial?
What benefits could I gain from participating?
Are there risks in participating in a clinical trial? If so, what are they?
Who covers the cost of my participation?
How much experience does SIMR have in conducting clinical trials?
Who ensures clinical trials are run correctly?
How do I find out about taking part in a clinical trial?
Who qualifies to take part in a clinical trial?
What is informed consent?
What if I want to quit?
What are my rights and protection if I decide to get involved?


Why does Sutter do research? | back to top
Our commitment to research stems from our desire to continually give you the most effective treatment and the best care. By providing physicians and medical specialists the opportunities and support they need to pursue advancements in their field, we give our patients access to cutting edge treatments. We also continue to attract the best, most dedicated and most innovative doctors to our team. Also see our mission page.

What is a clinical trial? | back to top
A clinical trial is a study that addresses specific health issues, tests promising approaches to new treatments with volunteers who meet certain criteria. To learn more about clinical trials in general, please see about clinical trials and see the clinical trials article in our health information section. The National Institutes of Health Web page "Understanding Clinical Trials" also provides an excellent explanation of clinical trials.

How do clinical trials come into being? | back to top
Clinical trials begin with a question by a principal investigator, generally a physician or research scientist, about the potential for a treatment approach, drug, medical device or diagnostic tool to provide an improvement in care. From the question, a carefully designed plan called a protocol takes shape. The protocol spells out, among other details, the goal of the study, how the drug or other agent will be administered, who qualifies to participate, how many participants are needed, what tests will be conducted and when. The protocol undergoes a thorough scientific evaluation by a Data Safety and Monitoring Board (DSMB) generally hired by the sponsor. Once evaluated by the DSMB, the protocol goes before an independent investigational research board (IRB) or committee (IRC) for approval. The IRB or IRC is a regulatory and compliance board specifically mandated to protect participants. Studies may be conducted at one or multiple sites. Multiple site studies, often used for drugs and medical devices, increase the number of investigators and participants to ensure enough data is gathered and to prevent investigator bias from skewing the results. SIMR participates in single and multi-site studies. Please see the section on the Sutter IRC to find out more about how studies are evaluated.

What happens during a clinical trial? | back to top
Clinical studies are designed to be safe and convenient for the participants while collecting important information about the treatment, device or drug being studied. Before deciding to join, participants are given background data to make an informed decision. For all types of trials, the participant works with a research team. Each potential participant receives an explanation that lays out what the participant will experience throughout the study and what is expected, including the study's span, instructions, travel requirements, doctor appointments and possible tests. The program varies according to each study, but according to the NIH, "some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition." Study sponsors cover the cost of the drug or medical device, appointments with doctors and other health professionals, and may also cover travel or other study-related costs.

Why would I want to participate in a clinical trial? | back to top
Clinical trials can provide participants access to promising, otherwise unavailable new treatments or diagnostic methods that may benefit them. Also, the study sponsor generally covers all related medical costs and expenses, which may include exams, medications, medical devices or even surgery related to the study. To learn more, please see our participant information section on this Web site.

What benefits could I gain from participating? | back to top
Because of the high costs to conduct clinical trials, only those medical advances that have shown significant potential in the laboratory move to the stage that includes human subjects. The company or other sponsor feels strongly enough about the drug, device or approach that they are willing to invest in the most complex, costly level of research. The hope is that the agent being tested will prove more effective than the current standard of treatment - a hope shared by study participants. Participants may gain access to the very latest in care for their condition that would not otherwise be available. They may also receive more frequent care and may undergo more tests and examinations that can be beneficial to their overall health. Regardless of the outcome of the study, every participant is helping others and contributing to furthering understanding of the human body.

Are there risks in participating in a clinical trial? If so, what are they? | back to top
Yes, there are risks in studies that involve drugs or medical devices for treatment. Generally, the types of trials SIMR undertakes are designed to test the safety and effectiveness of an agent across a broad population. Although clinical trials are carefully designed to be safe and worthwhile, each person may respond differently. Some may benefit from a new therapy, while others may not respond at all or may experience side effects that can be serious or even life threatening.

Who covers the cost of my participation? | back to top
The sponsor of the study covers participant medical costs, including the drug or medical device being investigated, medical examinations and tests, and care from the study physician and other medical professionals. In some cases, travel costs may also be covered. Recent legislation also allows insurance to cover some research costs, especially in cancer and some medical devices. It's important to remember that expenses incurred for time off from work, childcare and other peripheral expenses are not likely to be covered.

How much experience does SIMR have in conducting clinical trials? | back to top
Sutter has been a center for medical research and advancement since 1959 beginning with the Sutter Research Foundation and, since 1986, the Sutter Institute of Medical Research. Many of our hundreds of clinical trials have resulted in significant medical advances. To learn more, please see our timeline of Accomplishments.

Who ensures clinical trials are run correctly? | back to top
Every trial SIMR undertakes is first approved by the Sutter Health Central Institutional Review Committee (IRC) or a central institutional review board connected to the trial sponsor to ensure the safety and worthiness of the trial. Even before our researchers consider participating in outside supported trials, the trial protocols have gone through independent review by the sponsor's Data Safety and Monitoring Board as well. During the inpatient trials, Sutter's IRC continues to monitor the study's progress and doctors constantly report the details of the trial for review by SIMR, Sutter IRC, and the study sponsor. Other studies are monitored by the sponsor's selected institutional review board.

How do I find out about taking part in a clinical trial? | back to top
You can ask your Sutter physician if there are trials available for your particular condition. Working through their doctors is the most common way participants find out about trials. Check back often, as SIMR continues to initiate and recruit for new studies.

Who qualifies to take part in a clinical trial? | back to top
Every trial has its own carefully established criteria participants must fit to take part in the study. The criteria are based on medical conditions being addressed and may include age range, sex, and exclusions based on medications the participant is taking or other existing medical conditions. Because studies must be certain to examine the drug, device or approach under uniform conditions, exclusions may be extensive and disqualify a large number of participants from participating. There are many studies available covering a broad range of different conditions and the criteria vary greatly.

What is informed consent? | back to top
Every participant in a clinical trial must give his or her informed consent, meaning they fully understand the risks and conditions of the trial and voluntarily choose to participate and accept the conditions of the trial. If English is not the participant's primary language, translation can be provided. The participant is provided with an informed consent document that must be signed before the participant can take part in the trial. The consent form describes study participants' rights, and includes details about the study, such as its purpose, duration, required procedures and key contacts. The informed consent document is for the participant's protection. It is not a contract and the participant is free to withdraw from the study at any time.

What if I want to quit? | back to top
Participants are free to end their participation in a clinical trial at any time and for any reason. For information on your rights as a participant, please see: Your rights

What are my rights and protection if I decide to get involved? | back to top
Participants' rights ensure that each participant will be treated with fairness and respect, their privacy will be guarded and they will receive all information important to health and safety. Also, participants have the right to refuse treatment or discontinue participation at any time. For a complete list of study participant rights and protection, please see: Your rights.

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