CSNF Department of Clinical Research
- Tara Caldwell – Regulatory Specialist
- Tiffany Dacus, CPhT – Regulatory Specialist/Pharmacy Technician
- Tamara Davis, CCRP – Observational Research Specialist
- Bhaloo Desai, PhD, CCRP – Clinical Research Coordinator
- Amanda Fallon, BA – Clinical Research Coordinator
- Kathy Flanagan – Data Analyst
- Adrienne Greenewalt, BS – Clinical Research Coordinator
Clinical Trials Frequently Asked Questions
What are Clinical Trials?
Clinical trials are research studies to test new and promising ways to treat diseases. Before a medication or procedure can be FDA-approved, it must be tested to make sure that it is safe and effective. All cancer drugs in use today were approved as the result of a clinical trial. In oncology, clinical trials are especially important because in the absence of high cure rates, nearly all therapeutic approaches are developmental in nature. CSNF’s goal is to provide patients with investigational and approved therapies without the need to travel to large treatment centers. Patients are able to receive advanced investigational treatments in the comfort of their community.
Should I Consider a Clinical Trial?
Clinical trials not only help advance the level of patient care for the future, they allow individual patients to benefit by receiving cutting-edge care before it is approved for general use. CSNF offers multiple clinical trials each month.
Choosing to take part is an individual decision based on your health and your medical condition. When you consider entering a study, you will be given all the information available and have the opportunity to discuss your options in detail with your health-care provider. Only you can decide if the study is right for you.
If you choose to participate and change your mind later, you are free to voluntarily withdraw from study participation at any time and for any reason. You will receive the same “high quality” care as those patients who are not participating in a clinical trial.
Will I be Treated Like a “Guinea Pig?”
You will always be treated with dignity and respect throughout the clinical trial process. Specially trained nurses and research physicians will monitor your progress, and your doctor will only recommend a treatment that he or she believes is right for you.
Will I be Given a Placebo “Sugar Pill?”
Individuals in a control group during a clinical trial receive the standard of care treatment for their conditions. If a treatment shows exceptional promise in helping combat the disease, patients are often “crossed over” from the control group into the trial group so they receive all the benefits of the new protocol.
What is the Purpose of Conducting a Clinical Trial?
A clinical trial takes new treatment protocols that work well in the laboratory and try them on patients. The purpose is to monitor how effective these treatments are on people and what, if any, side effects occur. Clinical trials are the final steps in the process of getting new treatments approved by the Food and Drug Administration.
What are the Phases of a Clinical Trial?
There are four phases. Each phase is designed to determine specific information about the potential new treatment including risks, safety, and effectiveness compared to standard therapy. The hope is that the new therapy will be an improvement over the previous standard therapy.
- Phase I trials are the first human trials for a new treatment and are usually limited to a small number of people (usually fewer than 20). The goal of a Phase I trial is to find the highest dose and the best way to give a new therapy without undesirable side effects. This phase is probably the most important step in the development of a new drug or therapy. Upon completion of Phase I trials, the information that has been gathered is used to begin Phase II trials.
- Phase II trials test whether a new therapy is useful to fight cancer. Phase II trials are open to more patients than Phase I trials, about 25 to 100 patients. In Phase II, doctors look for side effects and to see whether the drug actually kills cancer cells in humans. Drugs or therapies that are shown to be active in Phase II trials may become standard treatment or be further evaluated for effectiveness in Phase III trials.
- Phase III trials test whether the new treatment kills more cancer than the currently approved standard (the most effective) treatment. Phase III clinical trials are open to many people, usually hundreds to thousands. Phase III trials require a large number of patients to measure the statistical validity of the results because patient age, sex, race, and other unknown factors could affect the results. These studies are conducted throughout the nation, and some are international. If a treatment is found to be safe and effective, the research is sent to the Food and Drug Administration for review. The FDA decides whether the new treatment can be used in the general public.
- Phase IV trials study treatments already approved by the FDA to find the best way to use the new treatment. Patients do not need to be in a study to receive the new drug since it is FDA approved, but can choose to participate.
How can I Learn More About Clinical Trials of Possible Interest to Me?
You should first talk to your physician to see if clinical trials are right for you. You can also learn about clinical trials around the country at the National Cancer Institute or by searching for available trials on ClinicalTrials.gov.
If you have questions regarding current clinical trial opportunities at CSNF, please call (904) 538-4488 or email Research@csnf.us for more information.