Frequently Asked Questions for Clinical Trials
What are clinical trials and why are they important?
Clinical trials are research studies that test how well new medical approaches work on people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of and progress against, cancer. They also receive up-to-date care from experts.
What are the types of clinical trials?
There are several types of clinical trials:
- Prevention trials test new approaches, such as medications, vitamins or other supplements that doctors believe may lower the risk of developing a certain type of cancer. Some examples of prevention trials at the LCRP are to prevent peripheral neuropathy (tingling/pain in extremities), chemotherapy-induced nausea and vomiting and various cancer recurrences.
- Screening trials study ways to detect cancer earlier. These trials involve people who do not have any symptoms of cancer.
- Diagnostic trials study tests or procedures that could be used to identify cancer more accurately. Diagnostic trials usually include people who have signs or symptoms of cancer.
- Treatment trials are conducted with people who have cancer. They are designed to answer specific questions about and evaluate the effectiveness of a new treatment or a new way of using a standard treatment. Many of the clinical trials at LCRP are treatment trials.
- Quality-of-life (also called supportive care) trials explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression or other effects from cancer or its treatment. The LCRP has a quality of life trial for head and neck cancer patients.
- Genetics studies are sometimes part of another cancer clinical trial. The genetic component of the trial may focus on how genetic makeup can affect detection, diagnosis or response to cancer treatment.
What are some of the benefits of taking part in a clinical trial?
The benefits of participating in a clinical trial include:
- Participants have access to promising new approaches that are often not available outside the clinical trial setting
- The approach being studied may be more effective than the standard approach
- Participants may be the first to benefit from the new method under study
- Results from the study may help others in the future.
What are some of the possible risks associated with taking part in a clinical trial?
- New drugs or procedures under study are not always better than the standard care to which they are being compared.
- New treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.
- Participants in randomized trials will not be able to choose the approach they receive.
- Health insurance and managed care providers may not cover all patient care costs in a study.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria." These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other healthcare professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial and stay in touch after the trial is completed.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it and the reasons for leaving the study.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), the Department of Veterans Affairs (VA) and the National Cancer Institute. Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices or community clinics.
What about my safety?
Government guidelines are in place to ensure that clinical trials are carried out with the safety of the subjects as a top priority. Your rights and safety are protected through informed consent, careful review and approval of the clinical trial protocol and ongoing monitoring.
The LCRP uses the St. Joseph's/Candler Health System Institutional Review Board (IRB) for studies, which is under the direction of Dr. Harold Black. An IRB is a group of people who review the research study to protect patient rights. IRB meetings at St. Joseph's/Candler are held on a monthly basis.
Who would take care of me if I was enrolled in a clinical trial at the LCRP?
The relationship between participant and clinical research coordinator is one on one. Oncology clinical research staff works in conjunction with the patient navigators, social workers, dietitians, physicians and entire cancer care team-many of whom are certified in their respective fields. Oncology clinical research staff presently consists of clinical research coordinators, team leader, clinical research associate, data entry coordinator and regulatory coordinator, as well as the medical director of the LCRP at St. Joseph's/Candler. Our research staff is trained and experienced in conducting research studies with reputable sponsors. Many of our system physicians are involved in research and serve as investigators for various studies.
What kinds of clinical trials are available at LCRP?
Where can I get more information about clinical trials?
You may call the National Cancer Institute's cancer information service at 800-4-CANCER (800-422-6237) or TTY at 800-332-8615 or visit www.cancer.gov/. For NCI's clinical trials information, go to www.cancer.gov/clinicaltrials/.
For information on Georgia CORE, go to http://georgiacore.org/.
Who do I contact?
For more information about clinical trials, you may contact a member of the research team at 912-819-5704 or your physician.
For information on common types of cancer, visit the National Cancer Institute.