Are there different types of clinical trials?
There are several different types of clinical trials. At Cancer Research for the Ozarks, the most common clinical trials offered are treatment trials and prevention trials. Treatment trials are conducted with people who already have cancer. Their purpose is to find better ways of using a current standard of treatment. It could be using new drugs or vaccines, new approaches to surgery or radiation therapy or new combinations of treatments. It is important to note that people on cancer treatment trials ALWAYS receive the current standard of care for their cancer. Adding new (but previously tested) treatment DOES NOT take the place of the usual treatment for their cancer. Prevention trials are conducted with people who have not had cancer or had cancer in the past. Control trials are done with people who have had cancer and want to reduce the chance of recurrence. Prevention or control trials may use new medications, vitamins or other supplements that are believed to help lower the risk of developing certain types of cancer.
How are people on clinical trials protected?
Clinical trials are conducted using very strict scientific and ethical principles. Every clinical trial has an exacting plan and process, called a protocol. The protocol describes what may or may not be done in the study, and why each requirement is important. The same protocol is used by every doctor and research center that takes part in it. All clinical trials that receive federal funding or evaluate a new medicine or medical device are subject to regulation by the federal Food and Drug Administration. The FDA requires that clinical trials be reviewed and approved by a local Institutional Review Board (IRB). The IRB has the power to accept or decline a trial, review a trial any time, and stop a clinical trial if it determines the protocol has not been followed correctly or possible harm could be caused to the participants. The IRB can also stop a trial if it clearly shows that the treatment is working well. That means the treatment could become more widely available more quickly. Because Cancer Research for the Ozarks has participants from both CoxHealth and Mercy, each health system has its own IRB.
What are clinical trials and why are they important?
According to the National Cancer Institute, clinical trials are research studies that test how well new medical approaches work for people. Clinical trials can provide scientific answers about better ways to prevent and treat cancer. As participants in a cancer clinical trial, people have the opportunity to contribute to important research in the fight against cancer.
What are eligibility standards and why are they important?
Each clinical trial has guidelines, or criteria, for who can and cannot participate. Eligibility criteria are different for each clinical trial, but no matter what the trial, each participant must exactly fit into the protocol’s requirements. Eligibility criteria may include age, gender, medical history, and current health status. For cancer treatment trials, eligibility criteria may call for patients to have a certain type and stage of cancer.
What are some of the benefits of being in a clinical trial?
- Participants have access to promising new approaches that often are not available outside of clinical trials
- The treatment or approach being studied may be more effective than the current standard.
- Participants receive regular, thorough care from their doctors and cancer research nurses.
- Participants may be the first to benefit from the new method being studied through the clinical trial.
What are some possible risks?
- New treatments may have unexpected side effects that could be worse than the standard.
- Participants in trials with several planned approaches won’t be able to choose which treatment they receive in addition to the standard treatment. They are “randomized”, meaning that they are selected for one group or another by chance.
What is Informed Consent?
Informed consent is the way people learn about all the important facts in a clinical trial. It includes facts about the clinical trial, the tests and procedures involved, and possible risks and benefits. The doctor and the nurse with Cancer Research for the Ozarks will thoroughly discuss informed consent with potential participants and their families. People who decide to become a part of a clinical trial will be asked to read and sign an informed consent document that thoroughly explains the clinical trial. Even though participants sign, they can still leave the study before they start or anytime during the study. Also, the doctor may take a participant off the clinical trial if he determines the participant cannot physically or mentally meet the requirements The informed consent is valid throughout the entire study, unless new benefits or risks are discovered. Researchers are obliged to update participants, and a new consent may be necessary.
People interested in taking part in cancer treatment or prevention trials should first talk to their doctor or health care professional
- Hulston Cancer Center at CoxHealth
- Chub O’Reilly Cancer Center at Mercy
- Cancer Research for the Ozarks (1730 E. Republic Road, Ste. V, Springfield MO, 65804, Phone 417-269-4520 or 1-800-821-753)
- At Cox Health, the Allenbrand Resource Center is located in the Hulston Cancer Center on the CoxHealth Campus (3850 S. National, First Floor, Springfield, MO 65807 – 417-269-5257)
- At Mercy, the Van K Smith Community Health Library is located in Mercy Cancer Center, Mercy Campus 417-820-2539 or 1-800-909-8326
- Cancer Information Service(CIS) is sponsored by the National Cancer Institute. Telephone: 1-800-4-CANCER (1-800-422-6237) TTY: 1-800-332-8615
- NCI Website: http://www.cancer.gov
- Live online assistance from NCI: LiveHelp at https://cissecure.nci.nih.gov/livehelp/welcome.asp
- Related resources and publications: http://www.cancer.gov/publications
- Finding clinical trials: http://www.cancer.gov/clinicaltrials/
- The National Library of Medicine offers links for finding results of clinical trials athttp://www.nlm.nih.gov/services/ctresults.html
- For information about Missouri’s Senate Bill 567 which mandates coverage for certain cancer clinical trials, go to link below and type in SB567 under the “Search for a Bill” section: http://www.senate.mo.gov/
Who pays for patient care costs that are associated with a clinical trial?
People considering participating in a clinical trial should have a frank discussion with their doctor or the nurse from Cancer Research for the Ozarks and get information from their health insurance provider . Many states, including Missouri, have health plans to cover some specific costs of clinical trials. According to the National Cancer Institute, health insurance plans and managed care plans may not cover costs associated with a clinical trial, especially if they are considered “investigational” or “experimental.” However if there is enough data showing that the approach in a clinical trial is safe and effective, a health plan may consider it “established.” It may be more difficult to get coverage for screening or prevention trials because health plans may not have review standards in place for these studies.