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Eligibility
| Risks | Benefits
| Cost | Patient
Rights
Clinical Trials are cancer treatments
or research studies that test new treatments in people with cancer.
They are designed to improve current treatments or compare seemingly
equal treatments. Research is carried out according to strict
scientific and ethical principles to protect patients and produce
sound results.
- Each clinical trial has a protocol or road map that explains
how it will work. The protocol must be approved by the
sponsoring organization, such as the National Cancer Institute,
and the Institutional Review Board at each hospital. This board
of consumers, clergy, and health professionals reviews the
protocol to assure that the research will not expose patients to
excessive or unethical risks. 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.
- Cancer clinical trials include research in three different phases. Each phase answers questions about the new treatment.
- Eligibility criteria differ for each study depending on the
research purpose. Inclusion criteria may ask about such things as disease stage and type, treatment history, age and kidney, heart, lung and liver function.
- Risks- There may be risks associated with participation in a clinical trial. The consent form provides a list of possible risks but there is also a possibility of previously unknown risks occurring. Patients may experience all, some or none of the expected side effects. The Ireland Cancer Center 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.
- Benefits – It is not possible to predict if patients will benefit from participation in clinical trials. Some clinical trials offer no benefit at all.
- Cost – 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.
- Patient Rights-Participation in a clinical trial is voluntary. Patients can decide not to participate or withdraw from a study at any time without penalty or loss of benefits. The rights of a patient do not change because they take part in a research study. The doctor can provide information about other treatment options.
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