What can I expect when I participate in a trial at the ICC?
There is a very specific set of rules that any institution offering clinical trials must follow when informing patients of the opportunity to participate in a trial. The process is called Informed Consent. It is designed to make the patient aware of all the possible risks and benefits of the trial.
Patients must sign a consent form in order to participate in a clinical trial. The consent form describes the purpose of the study, study treatment and procedures, risks, benefits, costs and alternative treatments. The consent form provides a list of possible risks but there is also a possibility of previously unknown risks occurring.
Discussion of benefits and risks
There may be risks associated with participation in a clinical trial. Patients may experience all, some or none of the expected side effects. The ICC has a data and safety committee which monitors clinical trials. Patients are kept informed about new information which becomes available about a clinical trial. Every effort is made to ensure patient safety.
By participating in clinical trials, not only are you taking an active role in a decision that affects your life, but you are also assisting in improving cancer treatment for others.
With any medical test, drug or procedure there are risks. These risks exist mostly in part due to the factor that some aspects of any new treatment are unknown. The result of a clinical trial maybe be proven effective for many people, but do not help everyone. There are no guarantees of the outcome of your clinical trial. Clinical trials in the early testing phase that have been studied only on a few people have more risk.
Cost of a trial - Financial & insurance issues
Some insurance carriers cover all or part of the costs of treatment on a clinical trial, while others do not. Often the sponsor of the clinical trial provides study drugs free of charge. Patients are not charged for research testing. It is important to determine ahead of time what the out-of-pocket expenses may be. Insurance carriers may deny coverage if the treatment is experimental, however, they may cover the costs if the study treatment is similar to treatment a patient could receive without being part of a clinical trial.
What costs are not covered?
Typically, the cost of investigational drugs, items, or services that are being tested as part of the clinical trial will not be covered under insurance. You will still have to pay any deductibles and coinsurance. Currently, Medicare doesn’t cover cancer prevention trials. If you are not sure whether your trial meets all of the requirements, discuss these concerns with your doctor or call the Medicare information number (1-800-633-4227). Contact your insurance company to ask exactly what cost they will cover for clinical trials.