Clinical trials are research studies that involve people and test new ways to prevent, diagnose and treat cancer and other diseases. Every clinical trial has a protocol, a set of guidelines and an action plan that describes how it will be conducted. These studies are closely regulated to protect the rights, safety and wellbeing of patients who participate in them.
At Peninsula Cancer Institute we have established a program to provide our patients access to the latest clinical trials related to cancer care. During the trials our research team of physicians, nurses, research assistants, data analysts and other specialists are committed to providing the best possible medical and supportive care while also helping each patient fully understand treatment options. The individuals who take part in clinical trials help contribute to our overall knowledge of cancer treatment while also receiving state-of-the-art care.
More on Clinical Trials and Research
Research is the most effective way we have to improve cancer treatments and give people with cancer the potential for a better quality of life. Clinical research into new and more effective types of chemotherapy is ongoing. If early studies suggest that a new treatment may be both safe and effective, further trials are carried out to find out whether it is better than existing treatments or has extra benefit when given together with these treatments. These trials compare the new treatment to the current best standard treatments.
Clinical trials are monitored by the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to insure patient safety and that clinical trial guidelines are followed. Each study has a primary physician called a Principal Investigator (PI), who oversees the study. Every study is approved by an institutional review board (IRB), which includes laymen, clergy, and health professionals who review the protocol to be sure that the research will not expose the patients to significant risk. In addition, each study enrolls people who are alike in key ways. Eligibility criteria differ from study to study, depending on the research purpose. The criteria that determine the studies participants are an important principle of medical research that helps produce reliable results.
Cancer clinical trials include research at three different phases:
Phase I trials are the first step in testing a new treatment in human beings. In these studies, researchers look for the best way to give a new treatment (e.g. by mouth? IV? Dose?). They find out if and how the treatment can be given safely and watch for harmful side effects. Phase I includes only limited numbers of patients.
Phase II trials focus on learning whether the new treatment has anti-cancer effects (e.g. does it shrink tumors?). As in Phase I, only a small number of people take part because of the risks.
Phase III trials compare the results from taking the new treatment with results from taking standard treatment. Phase III trials may include a much larger number of people than Phases I and II.
Because clinical trials play a key role in assessing how useful a new treatment might become, they are carried out with extreme care and thoroughness. When new drugs are developed, generally by pharmaceutical companies, there is often a great deal of publicity in the media that focuses on what the medication might be able to achieve. Because our government maintains stringent policies to make sure new drugs are as safe and effective as possible, there are long periods between the time when a possible new treatment is discovered and when its value can be established. It is during this period that clinical trials can help transform new discoveries to standard treatments.
If you have been offered the opportunity to take part in a clinical trial, there can be many benefits to your participation. You will be carefully monitored during and after the study and you will be helping to improve knowledge about cancer and the development of a new treatment. It is important to bear in mind that some treatments which look promising at first may, ultimately, be found to be less effective than existing treatments, or may have side effects that outweigh the benefits.