Frequently Asked Questions (FAQs)
Welcome to the Clinical Trials Office information page. Here you will find information on clinical trials: what they are, who can participate, and how they work.
What is a Clinical Trial?
A Clinical Trial is a study in humans carefully designed to help determine if a treatment, a medical procedure or method is safe and effective to the general public.
Why are Clinical Trials Important? <Back to Top>
Advances in medicine are the result of new ideas and approaches developed through research. Before they can be made available to the general public, new cancer treatments must prove to be safe and effective in clinical trials with specific populations of patients.
Through clinical trials, researchers learn which drugs and procedures are safe, and which are most effective. Most standard treatments in use today were first shown to be effective in clinical trials. These trials help us find new and better treatments.
What are the Types of Clinical Trials? <Back to Top>
- Treatment Trials - test new therapies that may increase the life expectancy or reduce suffering in people who have a serious illness.
- Prevention Trials - test new approaches like medicines, vaccines, vitamins, minerals or other supplements that doctors believe may lower the risk of a certain disease.
- Detection Trials - test the best way to find a disease, especially in its early stages.
- Supportive Care Trials - explore ways to improve comfort and quality of life for patients with a disease.
- Genetics Trials - meant to improve the ability to look for an inherited risk of illness.
What are the Stages of the Clinical Trials Process? <Back to Top >
Most new treatments are the result of new ideas generated from initial laboratory experiments. When researchers are ready to evaluate a new treatment or test in people, they carefully design clinical trials to test the treatment's effectiveness, its safety, and its side effects. Clinical trials follow an orderly progression of steps or phases (designed by the Food and Drug Administration, or FDA) to take the drug or procedure under study from discovery to approval.
- Phase I Trials: The purpose of a Phase I trial is to define the best dose of a new drug, its side effects and, potentially, the types of cancer against which this new drug may work. These trials are first-in-human studies and represent a critical step in drug development from the laboratory to the clinic. Most standard cancer treatments were first studied in Phase I clinical trials, and these studies provide an opportunity for a late-stage cancer patient to receive a new type of treatment if his/her cancer does not respond to standard treatment or if there is no standard treatment available. About 15-30 patients are usually enrolled in phase I trials.
- Phase II Trials: A Phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. These studies usually focus on a particular aspect of a disease. Like phase I trials, these trials do not test the differences between two therapies, so the participants will almost always get the experimental treatment. About 50-100 patients are usually enrolled in phase II trials.
- Phase III Trials: A Phase III trial tests a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard for treatment. A participant will usually be randomly assigned to the standard treatment group or the new treatment group. Phase III trials often enroll thousands of people and may be conducted at many doctors' offices, clinics, and disease centers nationwide.
- Phase IV Trials: In Phase IV trials, researchers study drugs and or treatments that have already received FDA approval. The goal of Phase IV trials is to study how safe and effective a drug or procedure is over time.
What is a Clinical Trial Protocol? <Back to Top >
A protocol is a detailed plan that follows strict scientific and ethical guidelines that explain what will be done in a clinical trial, how, and why. These guidelines cover many areas, including the study's design, who can be in the study, the eligibility criteria, and the kind of information people must be given when they are deciding whether or not to participate.
What is an Informed Consent? <Back to Top>
Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to discussing a clinical trial with a doctor or nurse, people are asked to sign a written consent form explaining the study. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study.
Are you Eligible for a Clinical Trial? <Back to Top>
Every clinical trial is designed to answer a set of research questions. If you fit the guidelines for a trial, you may be eligible to take part. Each study enrolls patients with certain types and stages of cancer and certain health status. A study that involves two or more treatments can yield reliable answers only if all the patient cases are the same so they can be compared with each other. Depending on the study you might be asked for personal information such as:
- gender (sex)
- age
- ethnicity
- education
- occupation
- lifestyle
You will also be asked for a variety of health- and illness-related information such as:
- site of cancer
- stage of cancer
- previous treatments
- previous treatment outcomes
- health and wellness background
- allergy history physical/functional status
- family history
Before a decision is made about your treatment (whether it is a clinical trial or not), your type of cancer will be diagnosed and "staged." Staging tells how far the disease has spread. Deciding on treatment depends on many things, including the stage of the disease and your general condition. You would most likely be referred to a trial by your own doctor or by a doctor who knows your case. Some patients find out about trials from other sources. In any case, you must have a reasonable understanding of your role in a research study and be freely willing to take part in it. Be sure to ask what you can expect if you take part in a trial.
What are Important Questions to Ask About a Clinical Trial? <Back to Top>
- What is the purpose of the study?
- What does the study involve? What kinds of tests and treatments?
(Find out what is done and how it is done.)
- What is likely to happen in my case with, or without, this new research treatment? (What may the cancer do and what may this treatment do?)
- What are other choices and their advantages and disadvantages? (Are there standard treatments for my case and how does the study compare with them?)
- How could the study treatment or test affect my daily life?
- What side effects could I expect from the study? (There can also be side effects from standard treatments and from the disease itself.)
- How long will the study last? (Will it require an extra time commitment on my part?)
- Will I have any costs? Will the treatment be free?
- If I am harmed as a result of the research, what treatment would I be entitled to?
- What type of long-term follow-up care is part of the study?
Clinical trial protocols often contain technical medical language not used in everyday conversation. Informed Consent forms, however, are required to be written in accessible and non-technical language. Many trials require that the patient be fluent in English. Some trials will also be conducted in a second language. If you do not speak English fluently, it still may be possible to participate in the study if you have a friend or a family member who is readily available to act as a translator between you and your health care providers.
