FAQ
Deciding to take part in a clinical study is an important step. There is a lot of information to understand and many factors to consider before you can make an Informed Consent to participate.
Here are some questions that patients frequently ask before making up their minds.
What are clinical studies, and why are they important?
Clinical studies are research studies that test how well new drug treatments work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical studies have an opportunity to contribute to building knowledge about cancer and progress in its treatment. They also receive up-to-date care from experts.
What is the MAGRIT study?
MAGRIT is a lung Cancer Treatment study. These are conducted with people who have lung cancer and are designed to answer specific questions about a new treatment or a new way of using a standard treatment, and specifically to determine how well this treatment works.
How are clinical studies sponsored?
There are a wide variety of organizations sponsoring cancer research and clinical studies. Government agencies, national health organizations, cancer institutes, research centers, foundations, volunteer groups, pharmaceutical companies, even individuals such as doctors sponsor clinical studies. This MAGRIT study is sponsored by GlaxoSmithKline (GSK).
How are participants protected?
Research with people is conducted according to strict scientific and ethics principles as defined by the Declaration of Helsinki. Every clinical study has a protocol, or action plan, which acts like a “recipe” for conducting the study. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Every doctor and hospital taking part in the study uses the same protocol.
This plan is approved by Authorities in each country (such as the Food and Drug Administration, or FDA, in the U.S.), and by committees evaluating whether ethics principles are respected. Prior to participating in a study, you will also receive a detailed plan of this study, including full information on what you are supposed to do and not do. This is called the Patient Informed Consent Form; each patient is required to sign it prior to participating.
What are eligibility criteria and why are they important?
Each study protocol defines clear criteria on the type of patients who can or cannot participate in the study. These criteria, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status. Eligibility criteria for Cancer Treatment studies often require that patients have a particular type and stage of cancer.
What is Informed Consent?
Informed Consent is a process by which people learn the important facts about a clinical study and, based on this information, freely agree to participate in the study. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible advantages of participating as well as the potential side effects.
In addition to talking with the doctor or nurse, patients receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the Informed Consent Form. However, signing the form does not mean that you have to stay in the study. People can leave the study at any time—either before it starts or at any time during the study.
Where do clinical studies take place?
Clinical studies take place in doctors’ surgeries, medical centers and all types of hospitals around the world. The number of participating healthcare professionals, medical centers and hospitals may vary from one study to another. Sometimes it involves hundreds of locations at the same time.
What are the different types of clinical studies?
There are several types of clinical studies. They are identified by the word “Phase”.
- Phase I studies are the first step in testing a new drug in people. In these studies, researchers evaluate how the drug is metabolized (transformed and eliminated) by the body, what dose is safe, how it should be given (by mouth, injected into a vein, or injected into the muscle), and how often. Researchers watch people closely for any harmful side effects. Usually, Phase I studies involve few subjects at few locations.
- Phase II studies evaluate whether a new drug has the potential to work, and what type of side effects it produces. The number of patients participating in these Phase II studies is usually a little higher than in Phase I studies (from tens to a few hundreds of patients).
- Phase III studies determine precisely how well a new treatment works and the side effects it produces. This new treatment is compared to a current standard therapy when such a therapy is available or to a placebo when no standard therapy exists. Participants are assigned by chance to the different treatments, usually by a computer. In most cases, studies move into Phase III testing only after they have shown promise in Phases I and II. Phase III studies often include large numbers of people – hundreds, or even thousands…
- Phase IV studies are conducted to evaluate on a long-term basis how well the treatment works and what side effects it produces. They take place after the treatment is commercially available. Several hundred to several thousand people may take part in a Phase IV study.
How are clinical studies conducted?
People who participate in a clinical study work with a research team. Team members may include doctors, nurses, social workers, dieticians, and other health professionals. The health care team provides care, checks regularly the participants’ health, and answers any specific questions about the study. So that the study results are as reliable as possible, it is important for participants to follow the research team’s instructions and to come back to the hospital each time they are asked to do so. The research team may continue to contact participants after the study ends.
What are some of the advantages of taking part in a clinical study?
The advantages of participating in a clinical study include the following:
- Participants may receive a new treatment not available outside the clinical study, and which may help treat the patient’s disease.
- Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
- Results from the study may help others in the future.
What are some of the possible risks associated with taking part in a clinical study?
The possible risks of participating in a clinical study include the following:
- It is not known how well a new drug or treatment may work.
- New treatments may have unknown side effects.
Where can I find more information about clinical studies?
In addition to the resources mentioned in Question 3, people interested in taking part in a clinical study should talk with their doctor.
Patients also have the option of searching for clinical studies on their own and can find very complete information on the Internet provided by national cancer associations and similar organizations.
References: http://www.cancer.gov/cancertopics/factsheet/Information/clinical-studys
… If you have any other questions or wish to discuss any of the above questions,
please contact a MAGRIT study doctor.
