What are clinical trials and why are they important?
Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists' knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts.
Are there different types of cancer clinical trials?
Yes. Cancer clinical trials differ according to their primary purpose. They include the following types:
- Treatment: These trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer.
- Prevention: These trials test new interventionsthat may lower the risk of developing certain types of cancer.
- Screening: These trials test new ways of finding cancer early.
- Diagnostic: These trials study new tests or procedures that may help identify, or diagnose cancer more accurately.
- Quality of life or supportive care: These trials focus on the comfort and quality of life of cancer patients and cancer survivors.
Who sponsors clinical trials?
Government agencies, such as the National Cancer Institute (NCI) and other parts of the National Institutes of Health(NIH), the Department of Defense, and the Department of Veterans Affairs, sponsor and conduct clinical trials. In addition, organizations or individuals, including physicians, academic medical centers, foundations, volunteer groups, and biotechnology and pharmaceutical companies, also sponsor cancer clinical trials.
Where do cancer clinical trials take place?
Cancer clinical trials take place in cities and towns across the United States and in other countries. They take place in doctors' offices, cancer centers and other medical centers, community hospitals and clinics, and veterans' and military hospitals. A single trial may take place at one or two specialized medical centers only or at hundreds of offices, hospitals, and centers.
Who manages clinical trials?
Each clinical trial is managed by a research team that can include doctors, nurses, research assistants, data analysts and other specialists. The research team works closely with other health professionals, including other doctors and nurses, laboratory technicians, pharmacists, dietitians and socialworkers to provide medical and supportive care to people who take part in a clinical trial.
What are eligibility criteria, and why are they important?
Every clinical trial has a protocol, or action plan, that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. The protocol also includes guidelines for who can and cannot participate in the trial. These guidelines, called eligibility criteria, describe the characteristics that all interested people must have before they can take part in the trial. Eligibility criteria can include age, sex, medical history and current health status. Eligibility criteria for cancer treatment trials often include the type and stageof cancer, as well as the type(s) of cancer treatment already received.
How is the safety of clinical trial participants protected?
National and international regulations and policies have been developed to help ensure that research involving people is conducted according to strict scientific and ethical principles. Clinical trials that are conducted or supported by agencies of the U.S. federal government or that evaluate new drugs or medical devices that are subject to regulation by the U.S. Food and Drug Administration(FDA) must be reviewed and approved by an Institutional Review Board(IRB). The IRB reviews all aspects of a clinical trial to make sure that the rights, safety and well-being of trial participants will be protected.
What are some of the possible benefits of taking part in a clinical trial?
The benefits of participating in a clinical trial include the following:
- Trial participants may have access to promising new interventions that are generally not available outside of a clinical trial.
- Trial participants receive regular and careful medical attention from a research team that includes doctors, nurses and other health professionals.
- The results of the trial may help other people who need cancer treatment in the future.
- Trial participants are helping scientists learn more about cancer (e.g., how it grows, how it acts and what influences its growth and spread).
Where can people find more information about clinical trials?
People interested in taking part in a clinical trial should talk with their healthcare provider. Information about cancer clinical trials is also available from NCI's Cancer Information Service(CIS). CIS information specialists use NCI's website to identify and provide detailed information about clinical trials that are currently accepting patients. People also have the option of searching for clinical trials on their own by visiting the clinical trials search form. Another resource is NLM's ClinicalTrials.gov, which lists clinical trials for a wide range of diseases and conditions, including cancer. For more information about the Warren Cancer Research Foundation/Oklahoma Community Clinical Oncology Program (CCOP), please call 918-491-5878.