Questions and Answers about Clinical Trials

Q: What is a clinical trial?

A: A clinical trial is one of the final steps in cancer research looking for better ways to prevent, screen for, diagnose, or treat cancer. A clinical trial tests a new medical approach in people, and is designed to answer a specific question. For example, is a new drug better than the one currently being used to treat a particular cancer? Cancer treatment clinical trials are conducted with people who have cancer. They are designed to answer specific questions about a new drug or therapy, or a new way of using an existing treatment.

Q: How is a new therapy tested in clinical trials?

A: A clinical trial is a careful and controlled process conducted in a series of steps, called phases. A Phase I trial is the first step in the process and answers basic questions about how a new drug or treatment should be used. In a Phase II trial, the treatment is tested for safety and effectiveness. Treatments that show promise in Phases I and II move to a Phase III trial, where the new therapy is compared with the common “standard therapy.” A phase IV trial further evaluates the long-term safety, effectiveness, and best use of a treatment that has been approved for standard use.

Q: Are there risks in participating in a clinical trial?

A: Treatments enter clinical trials because they have shown strong promise in the laboratory. Results in the clinic, however, may be different. The new therapy may not be better than the standard treatment or it may have unexpected or more difficult side effects. If the study is comparing different treatments, participants cannot choose which one they receive because they are randomly assigned to one treatment or the other. Also, participants should discuss costs before participating, to be sure that costs are covered by health insurance or the study sponsor.

Q: Are there benefits to participating in a clinical trial?

A: As a part of a clinical trial, participants receive extensive and careful medical attention from a team that can include doctors, nurses, researchers, and clinical trial coordinators. They also have access to promising new therapies, which in some cases may be the best current option for treatment. Ultimately, people who take part in clinical trials contribute to progress against cancer—helping to shape promising new approaches in the fight against cancer.

Q: Are participants protected?

A: Clinical trials are conducted according to strict scientific and ethical principles. Every clinical trial has a plan, called a protocol, which describes what will happen in the study and why it is necessary. Before a clinical trial begins, the protocol is reviewed and approved by Dartmouth’s Institutional Review Board (IRB) and the Cancer Center’s Clinical Cancer Review Committee. They make sure the study has a strong scientific basis and that participants are not likely to be harmed. They can stop a clinical trial that is not following the protocol or is causing unexpected harm to participants. They also can halt a clinical trial if the new therapy is very effective, in order to make it available to patients who are not on the trial.

Q: What are eligibility criteria?

A: Eligibility criteria define who may participate in a clinical trial. In order to answer a specific question about a new approach to cancer care, variables such as age, gender, medical history, stage, and type of cancer need to be kept the same. Eligibility criteria define common characteristics, and help researchers achieve accurate and meaningful results. Eligibility criteria also minimize the risk of a person’s condition becoming worse by participating in the study.

Q: What is informed consent?

A: The process of informed consent gives people the information they need to decide if they want to participate in a clinical trial. Topics such as the purpose of the study, the tests and procedures involved, and the possible risks and benefits, are discussed and included in an informed consent document that is signed by the participant. Participants may be asked to sign new consent forms as new benefits, risks, or side effects are discovered. People can leave a study at any time—before the clinical trial starts or at any time over the course of the trial.