Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug, vaccine, or device is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment. CVI trials focus on many types of cancers including breast, ovarian, and lung.

Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects. Clinical trials of drugs or vaccines are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.

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• A Phase I trial tests an experimental treatment on a small group of often people (20 to 80) to judge its safety and side effects and to find the correct drug/vaccine dosage.

• A Phase II trial uses more people. While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.

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• A Phase III trial tests the effectiveness of the experimental treatment compared to the standard of care to determine which works better. These trials gather information about safety and effectiveness in larger patient populations, ranging from several hundred to about 3,000 people. These trials may also combine the treatment with other drugs. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

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• A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

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CVI typically does Phase I and II trials which have study objectives to identify which dose is most safe and effective by looking at side effects and the immune response.

Our clinical trials are open to anyone over the age of 18 who meets the studies eligibility criteria. Medical records are collected from your physician and reviewed to see if you would be a good candidate. We may ask you to come in for a screening visit so certain tests can be conducted to ensure your eligibility (examples: additional blood work, imaging, heart tests). If English is not your first language, a translator will be available and a short consent form may be able to be translated to your language. If your records are not in English, you will have to have them translated to English. If you live out of the country or do not have insurance, you will be responsible for any costs outside the typical costs for the study.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Participating in a clinical trial means you are a very special person. Less than 5% of adults enroll in cancer trials. You may not personally benefit (although we hope you do) from the trial, but you will be helping move science forward to developing different treatments and strategies to help others.

The potential benefits of participating in a clinical trial may include the following:

• Access to promising new treatments often not available outside the clinical trial setting.

• Treatment that may be more effective than the standard approach.

• Close monitoring, advice, care, and support by a research team of doctors and other health care professionals who understand your disease or condition.

• The opportunity to be the first to benefit from a new method under study.

• The chance to play an active role in your own health care and gain a greater understanding of your disease or condition.

• The chance to help society by contributing to medical research. Even if you don't directly benefit from the results of the clinical trial you take part in, the information gathered can help others and adds to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care.

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The potential risks of participating in a clinical trial may include the following:

• The trial may require more visits to Seattle, and more and bigger blood draws, than your previous treatments.

• There may be unpleasant, serious or life-threatening side effects to experimental treatments. We will let you know of all known and expected side effects.

• Since we do early phase trials, we don’t know all the side effects but will let you know if we see any concerning trends. The study may then be stopped or changed a bit to reflect the concerning trends.

You will be given a copy of the consent form during the screening process. Please review it carefully and talk with your medical provider, family and or friends about the trial. We will do our best to answer any questions before you decide to come in. We can also talk with your medical provider if they have questions. We want you to be sure you want to be part of the trial.

Informed consent is the process of communication between the clinical trial participant and a member of the research team that occurs before any trial-related procedures are done. The research team member (typically the study physician) will read and discuss the consent which includes information on the trial’s purpose, procedures, risks and potential benefits, and the participant's rights. You will be given a copy of the consent in advance so you have time to review it before the discussion. Ample time is given for discussion and the participant is encouraged to ask questions and should not sign the consent unless they fully understand the scope of their participation.

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It is always good to have a family member or friend accompany the participant to the consent conference so they too can ask questions. If you want to participate in the study, after this conference you and the research team member will sign the consent. You will be given a copy of it.

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Informed consent(s) are revised every time new safety information becomes available or there is a change in trial procedures, participant compensation or personnel noted on the consent form. The consent will be reviewed with you with the new information.

Clinical trials are designed to minimize risk to the patient. Some side effects may occur from treatments administered as part of the clinical trial. These side effects will be explained on the Informed Consent Form. There may be side effects we do not know about yet. If we learn about other significant side effects, you will be told. We carefully watch everyone in the study for side effects. Researchers generally refer to study side effects as adverse events or reactions.

Safety is of utmost importance in our clinical trials.

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All of our study protocols (plans that describe the study in detail) are reviewed by Institutional Review Boards (IRB) that make sure the study will look at worthwhile questions and ensure the safety of the people on the trial.

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Our studies also have an independent Medical Monitor who reviews any serious side effects. The CVI also has an ongoing review of the safety of our study drugs for the participants. Protocols may be changed or studies ended if we observe any serious side effects that might endanger participants.

Yes, you can leave a clinical trial before it’s completed.

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During the study, we might learn new information that you would need to know. For example, if we learn new information that may affect your health or well-being that might make you change your mind about being in this study. If we learn this kind of information, we will tell you.

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If you join the study, you do not have to stay in it. You may stop at any time (even before you start). Importantly, your regular medical care will not change if you join this study. There is no penalty for stopping, but it is better not to join the study if you think that you will change your mind later.

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If you decide to drop out/withdrawal from the study procedures, we will want you to tell a research team member so they can tell you about any possible side effects you may need to look for or any follow care or testing that would be helpful. We may want you to come back for a safety/end of treatment visit. We may want to follow your progress and any side effects you may have developed.

You can find information on ongoing CVI clinical trials here. For information on all clinical trials in the United States, visit www.clinicaltrials.gov.

Overall results of our studies are shared once the study has been published in a scientific journal or presented at a scientific conference. As clinical trials take many years to complete and can include long-term follow-up, it can take many years before the results are made available.

Most CVI clinical trials take place at the University of Washington’s Translational Research Unit. More information on address and directions can be found here.

You do not have to pay to be in a clinical trial. The costs related to a clinical trial depends on the study.

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There is no charge for the medical costs directly related to the clinical research testing/procedures. Your insurance company may cover costs for routine care associated with the study. You should ask which procedures are routine care. You may want to talk with your insurance company about its payment policy for routine care given during a research study. If your insurance company does not pay, you may be billed for those charges. Your insurance company may disagree with your study doctor about which tests and/or procedures are considered routine care. If your insurance company believes these tests and/or procedures are related to the research study they may deny payment, which would make you responsible for any charges that are not paid for by the study sponsor. There is never any guarantee with any hospital service that you will not have to pay for any of these services.

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There are no funds to pay you for a research-related injury, added medical costs, loss of a job, or other costs to you or your family. State or national law may give you rights to seek payment for some of these expenses. You do not waive any right to seek payment.

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Some studies may pay volunteers for their participation and/or travel expenses. This is study dependent.

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There are some organizations, that you may pursue, that could assist with lodging/travel: https://www.uwmedicine.org/patient-resources/lodging-options.

Yes, we have participants from all over the world come to Seattle for our trials. We have had patients from Canada, Peru, England, New Zealand and all over the United States. We do not pay or arrange any travel or lodging, but can offer some resources for you to pursue. It is important to note, that we cannot guarantee your eligibility until you have met in person, with the study physician and the inclusion and exclusion criteria are reviewed with you. It is possible that there may be some restrictions on out of state and foreign patients for some studies.

We may be able to connect you with a past participant from one of our clinical trials. Reach out to us.