Research is an incremental process that moves forward in small and carefully planned steps. Usually research begins as basic science in the lab and after years of testing in cells and tissues, testing is done on animal models of human cells. After treatments prove successful in animals, these treatments may be tested on people through clinical trials.
A clinical trial is a research study designed to answer questions about safety and effectiveness of a drug or treatment. These trials follow a rigorous scientific process with built-in safeguards for participants who volunteer and are selected for research. Most clinical research involves the testing of a new drug in an orderly series of steps called phases. The process starts with small trials testing the safety of a treatment and then moves towards progressively larger trials. The larger trials compare the safety and effectiveness of the new therapy to the currently accepted standard of care.
It is important to remember that in a clinical trial, researchers do not know if the new treatment will be more effective than the current standard of care treatment.
A committee of nurses and doctors at the Leukemia/BMT Program reviews all clinical trials proposed by the Leukemia/BMT Program. The purpose of the Review Committee is to ensure that the trials are clinically and scientifically sound.
Once the protocol has been accepted by the Leukemia/BMT Program Review Committee, the study protocol must be approved by an Ethics Board. Before a trial can go ahead, the Ethics Board must be satisfied that the trial addresses an important scientific question, is well planned, is as safe as possible for the patients, and is ethically sound.
Before participating in any clinical trial, patients must sign a consent to ensure that they are fully informed and thoroughly understand the study protocol and the risks and benefits of their participation.
Your medical information is confidential, but individuals involved in monitoring the conduct of the study and recording information on the treatments may need to access your records in the presence of a study investigator. These individuals may be representatives of the study sponsors, such as the National Cancer Institute of Canada (NCIC) or the drug company supplying the trial drug. They may also be representatives from regulatory bodies such as Health Canada's Health Protection Branch.
Any forms or paperwork recording your information and results will identify you by code number only, and your name will never appear in any publication resulting from the study.
You do not waive, or sign away, your legal rights by signing consent to a study. Taking part in a study is voluntary. This means you may choose not to take part, or may withdraw your consent and leave the study at any time. If you withdraw from or decline a study, your doctor will discuss further treatments with you and continue to treat your cancer with the best means available. If there are other clinical trial opportunities relevant to you later in your treatment, these will be offered to you.
In addition to you deciding whether the trial is right for you, your hematologist will have to make sure you are right for the trial. All participants must meet the eligibility criteria as written in the study protocol. After the consent form is signed, tests to determine the status of your disease and other baseline tests, such as blood, urine, or heart tests may be necessary to determine your eligibility.