Clinical Trial: What You Need to Know
Cancer clinical trials, also called research studies, test many types of treatments such as new drugs, new surgical techniques or radiation therapy, new combinations of treatments, or new methods. The goal of the research is to find better ways to treat cancer. Cancer clinical trials include research at four different phases. Each phase answers different questions about the new treatments.
What Happens in Cancer Clinical Trials?
In clinical trials, patients receive treatment and doctors carry out research on how the treatment affects patients. A person’s progress is closely monitored during the trial. Once the treatment portion of the trial has been completed, patients may continue to be followed in order to gather information regarding specific endpoints. These endpoints are defined prior to the study being started and may include time for disease progression and/or overall survival.
While clinical trials have risks for the people who take part, each study also takes steps to protect patients.
Informed Consent
Informed consent is an ongoing process during a cancer clinical trial in which all of the available information about the specific trial is discussed with the person participating in the trial. The doctor or nurse reviews the treatment plan, including potential risks and benefits of the treatment with the participant. This information is also written in a document (consent form) which is presented to the participant before treatments can begin. After the potential study participant reads the document, an opportunity to ask questions about any parts of the form that are unclear is given. If the person agrees to participate in the study, the consent form is signed. Signing the form indicates that the study participant read the form and the doctor or study nurse answered any questions about the information contained in the form, which may have been unclear. Signing a consent form does not mean a person must stay in the study. In fact, a person may leave the study at any time. If a person chooses to leave the study, a chance to discuss other treatments and care with their doctor is given, and their care will not be affected in any way.
Protocols
The protocol is the action plan for a clinical trial. The plan states what will be done in the study and why. It outlines how many people will take part in the study, what types of patients may take part, what tests they will receive and how often, as well as the treatment plan. Each doctor that treats patients in the study uses the same protocol, and must follow the guidelines that are specified. The federal Food and Drug Administration (FDA) has general guidelines that must be followed by any physician or institution conducting clinical trials. Before the FDA can approve a treatment, the study results are audited to ensure the trial was conducted safely and according to these guidelines.
For patient safety, each protocol must also be approved by the organization that sponsors the study. The Scientific Review Committee, a group of individuals from the institution, including physicians, scientists, nurses, administrators, review the protocol for scientific merit and feasibility of the protocol. The Institutional Review Board (IRB) of the hospital must also approve it. This board includes consumers, clergy, and health professionals. They review the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.
Eligibility Criteria
Eligibility criteria are guidelines from the protocol, which describe the characteristics that all participants in the study must have. These criteria differ from study to study, depending on the purpose of the research. Examples are: age, gender, the type and stage of cancer; and whether cancer patients who have had prior cancer treatment or have other health problems can participate.
