What is a clinical trial?
A clinical trial, sometimes referred to as a study or study protocol, is designed to evaluate whether new drugs, intervention or treatments are both safe and effective. A protocol is a study plan on which the clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes who may participate in a specific research trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What does a Phase I, Phase II, Phase III and Phase IV clinical trial mean?
Clinical trials are divided into four phases: Phase I, Phase II, Phase III and Phase IV. Each phase is designed for a different purpose and answers a different scientific question. Clinical trials, also called medical research or research studies, are used to determine whether new drugs or treatments are effective at treating or preventing disease. While the Tumor Vaccine Group only focuses on Phase I & II, knowledge of all phases is beneficial.
What is a Phase I trial?
A Phase I clinical trial is the first phase of a study that is carried out on human subjects. This occurs only after appropriate research has been done in animal or cell models. The phase I trial is designed to determine dose scheduling, toxicity, safety, and feasibility of a treatment. Its purpose is to determine whether a drug or treatment will be safe for humans and whether it appears to function as expected. Most phase I trials are not designed to answer whether a treatment is effective on the growth of cancer. If a phase I trial proves the new treatment is safe, the treatment can then be tested for its effectiveness as an anti-cancer agent. Phase I trials usually take place at only one treatment center and involve a limited number of patients.
What is a Phase II trial?
A Phase II clinical trial explores therapeutic efficacy of a new drug treatment while continuing to monitor safety. In other words, this phase of study begins to answer whether this intervention works. This type of trial is usually performed on a small number of patients (often less than 100) with the same disease characteristics.
What is a Phase III trial?
A Phase III clinical trial is carried out once efficacy is established. This type of trial compares the new drug treatment to an existing standard drug treatment for the same diagnosis. This type of trial usually involves large numbers of patients (more than 100) and is performed at several different cooperating institutions. These types of studies are often "randomized," meaning that patients are randomly assigned to one treatment or another. Sometimes, phase III studies are also "double-blinded" and "placebo-controlled." Double-blinded means that the study subjects and investigators are not aware of which treatment is being given to any one individual until after the study is completed. Placebo-controlled trials compare a new treatment to a placebo, or inactive treatment or substance.
What is a Phase IV trial?
A Phase IV clinical trial is carried out as the final phase of new drug therapy investigation. In a phase IV trial, the new drug is used as standard therapy to determine optimal use of the drug for large patient populations.
Why do cancer patients participate in clinical trials and why is it beneficial?
Patients may participate in clinical trials because they are looking for alternatives to help cure their cancer or to help them live longer. There is no guarantee, however, that an experimental treatment will be effective, particularly in phase I trials. We are not sure if patients will benefit from this study. However, future patients with cancer may benefit from this study.
Who are the medical professionals involved in clinical trials?
A clinical trial is carried out by a multidisciplinary research team composed of basic science researchers and clinicians.
- The Principal Investigator is the professional who is responsible for the scientific integrity of the study.
- In clinical trials of new cancer therapies, physicians who are cancer specialists (oncologists) and research nurses manage the clinical elements of the study. This might include counseling and examining patients, giving medication, or performing procedures depending on the study and its structure.
- A team of laboratory researchers and scientists may also be involved behind the scenes analyzing material and information obtained during the study.
What else should patients know about experimental cancer therapy trials?
You must be informed of your rights with respect to participation in a clinical trial. This includes a written informed consent in a language you can understand that discusses the risks and benefits. You should sign and receive a copy of the consent form. You will have the opportunity to ask questions before, during, and after a clinical trial. Your decision to participate in a clinical trial is completely voluntary and you have the right to withdraw at anytime without penalty or loss of benefits.
What are costs involved in participating in a research trial?
The consent form for each study goes into specifics of what the financial costs are for each study. The cost of coming to the University of Washington Medical Center, such as flights, travel expenses and hotel rooms will be paid by you as we do not have the funding to provide accommodations.
Financial compensation for participation in a study is study dependent. As a basic rule, blood draw studies (where we ask you to donate blood for the sole purpose of a study) will have some financial compensation for time.
There is no cost for anything related to the study.
All research physician visits related to the study are provided.
All clinical and laboratory testing for the study are provided.
The "treatment" for the study is of course provided at no cost. This is different depending on the study. For example, "treatment" may be:
- Your own T cells expanded (grown) into the billions and prepared for infusion back into you. There is no cost for the expansion and infusion of these cells.
- A vaccine against HER2/neu. There is no cost for the vaccine or the administration of the vaccine.
- Chemotherapy or immunomodulation with medications such as ONTAK® or GM-CSF is provided at no cost.
Where are the trials being done?
Currently all our study visits take place at the University of Washington Medical Center or the Seattle Cancer Care Alliance in Seattle, Washington.
If I'm not eligible for your studies, where else can I look to find trials in which to participate?
ClinicalTrials.gov is the best place on the Internet to look for clinical trials, though will not be limited to cancer trials.
The National Cancer Institute is the best place on the Internet to look for clinical trials for cancer patients.
The Fred Hutchinson Cancer Research Center has a section on their web site where you can search for trials ongoing on the University of Washington, Seattle Cancer Care Alliance, Children's Hospital and Regional Medical Center and of course the Fred Hutchinson Cancer Research Center.
Finally, your doctor may know of other trials which may be appropriate for you in your area.