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Eligibility to participate in a clinical trial depends on the trial’s inclusion criteria. Inclusion criteria determine who is eligible to be part of the trial. Criteria are a set of standards based on a patient characteristics such as type and stage of disease, gender, age, and prior treatment history.
Most trials involve some risk but they may not be greater than those risks related to routine disease progression and medical care.
The effectiveness and safety of the product in the trial might not be known. Some trials may benefit participants medically, but others might not.
Study protocols vary and participants may have to undergo additional procedures, tests, or assessments during the course of the clinical trial.
The overall purpose of a clinical trial is to contribute to medical knowledge. These trials can affect the care of future patients.
New treatments could have unexpected side effects and risks that are worse than that of the standard option of care.
Costs that a participant may have as a result of the study might not be covered by health insurance and managed care providers.
Even if you are seeing positive effects from the intervention, the intervention may not be approved by regulatory agencies.
Participants in randomized trials are assigned whether or not they will receive an intervention that is being tested. They cannot choose. “Randomized” means that a person is randomly assigned to an intervention group to receive treatment or to a control group to receive a “placebo” or usual care.
Additional doctor visits may be required.
Each participant must provide informed consent to be part of a clinical trial. To make an informed decision, participants are provided with information on the study. In addition to this informed consent document, participants may receive recruitment materials, verbal instructions, or question and answer sessions.
To further protect the participant, an institutional review board (IRB) reviews, approves and monitors clinical trials and studies of drugs, biological products, and medical devices that are regulated by the FDA. The IRB ensures that a study is ethical and that the participants rights and welfare are protected.