Clinical Trials Frequently Asked Questions
What are clinical trials?
A clinical trial, commonly referred to as a clinical study or research study, is a study conducted with patients to evaluate a new treatment. Each study is designed to determine if a new drug or treatment will work on a disease or potentially be of benefit to patients. Through clinical trials, doctors and researchers are able to gain information on the benefits, side effects and possible applications of new drugs, as well as different combinations, doses and new uses for existing drugs.
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What are the phases of clinical trials?
There are four research phases of a clinical trial:
Phase I
The drug is only given to a small number of patients. Researchers look for the best way to give the new treatment. If the drug proves to be safe, the trial proceeds to Phase II.
Phase II
The drug undergoes testing to determine its effect on different types of cancers. Researchers also look for ideal dosing ranges and possible side effects.
Phase III
If the drug shows activity against the cancer, it is then compared with common or standard therapies. Researchers want to establish which is more beneficial. The patients who take part in this comparison are randomly chosen to receive either the new treatment or the standard treatment. Those receiving the standard therapy are referred to as the control group. The control group receives the best available standard treatment. Phase III studies usually include hundreds of participants around the country.
Phase IV
This phase continues the assessment of the safety and effectiveness of cancer therapies already FDA approved and available for the general public.
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Why are clinical trials important?
Clinical trials provide advances in medicine and science. New cancer treatments must be proven to be safe and effective. Through these scientific studies, researchers are able to conclude which methods of treatment are most successful.
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Why should I participate in a clinical trial?
There are many advantages to enrolling in a clinical trial at the Cancer Center. Not only does the participant benefit from a study that may prove to be a superior treatment, but others also benefit from the increased knowledge the study provides. All patients in a clinical trial are carefully monitored during and after the study.
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What are the risks in clinical trials?
The treatments used in clinical trials can cause side effects and other health risks depending on the type of treatment and the patient’s condition. Cancer treatment is particularly powerful because it is designed to destroy constantly dividing cancer cells. It can also affect healthy cells, and this can cause side effects. Side effects vary from patient to patient. Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what these risks might be. For this reason, trials can carry unknown side effects as well as hoped-for benefits.
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Who oversees the clinical trials?
An Institutional Review Board (IRB) oversees the action plan or protocol related to each clinical trial conducted at the Cancer Center. The IRB is comprised of physicians, medical specialists, nurses, social workers, medical ethicists and patient advocates who have no special interest in any specific trial. IRB members are responsible for reviewing protocols to ensure patients are not exposed to unethical risks. These boards also ensure trials are conducted with the full consent of each patient.
Kamal Bakri, M.D., serves as both the medical director for the Medical Oncology Department and principal investigator for the Cancer Center’s clinical trial program. Kim Martinez RN, OCN, Research Coordinator serves as research coordinator.
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What if I change my mind about a clinical trial?
Participating in a study is completely voluntary. Clinical trials do require a participant be able to receive a treatment and submit to monitoring and follow-ups. However, patients who join a study are free to withdraw at any time. If you decide to leave the study, it will in no way affect your medical treatment at Cape Fear Valley Health System.
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What are the costs for a clinical trial?
In most cases, patients and the trial sponsors are financially responsible for clinical trial costs. Drugs offered in the study may be supplied by the pharmaceutical company through the National Cancer Institute; however, patients participating in the study may be responsible for routine costs, such as doctor visits, lab tests, scans, x-rays and hospital fees.
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What clinical trials are available at the Cancer Center?
Answer
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