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Hearing the word cancer from your healthcare professional can be an overwhelming experience. Whether the diagnosis involves you, a friend or family member, there will be many questions in the days ahead. Sifting through the masses of information available about the diagnosis, finding the best doctors, understanding treatment options and side effects, can be exhausting by itself. In addition to the routine knowledge that must be gained quickly, there may be many questions
about the latest research in cancer.
The good news is that the treatment for most types of cancer, has improved dramatically over the last several decades. How is this possible? Advances in cancer treatment and cures have come about through clinical trials. Clinical trials are formal research studies that involve people, and test new medications or medical equipment to determine whether they are safe and effective for patients with a specific cancer.
In the United States, all medical devices and drugs, whether prescription or “over the counter,” must be approved by the U.S. Food and Drug Administrations (FDA). Clinical trials are the studies that can lead to FDA approval of a new drug or device. Such trials are generally conducted in specific steps, called Phase I, II, and III. Each clinical trial is supervised by a “sponsor,” which may be the National Cancer Institute, a drug company, or the institution where the patient is being treated. All trials must be reviewed and approved by the local Institutional Review Board (IRB).
In Phase I trials, small groups of patients receive new drugs at low doses to uncover whether a drug is safe or not. Once the safe dose of the drug is identified, the trial is stopped. In Phase II, the safe dose is given to a larger group of patients, to determine whether the drug works against the specific type of cancer being studied. Generally, Phase II trials study a new drug that is not yet FDA approved, or is approved in a different type of cancer. All patients receive the drug that is being tested.
Phase III trials compare the new treatment to the current standard treatment to see if it gives a better result for patients. Patients who agree to participate in a Phase III trial are randomly assigned to one of the treatment groups. It is common in Phase III trials that both the doctor and the patient do not know which treatment the patient is receiving – known as “blinding.” The purpose of blinding is to remove bias from the study so that the benefits and side e ects can be fairly evaluated.
When a patient is offered a clinical trial as a treatment option, they will go through a process called “informed consent.” The informed consent documents help patients decide whether to participate in a research trial, and will describe the purpose of the study, tests and other procedures used, the study schedule, and the possible risks and benefits. All personal and health information obtained as part of a clinical trial is kept confidential in the same way as all other medical information is protected.
Article provided by the Medical University of South Carolina.
