Choosing to participate in a skin cancer clinical trial can have both risks and benefits.
The benefits of participating can include:
The opportunity to have access to new forms of therapy that you wouldn't be able to try if you were not in a clinical trial
The possibility that the treatment being tested may be better than the standard way of treating your disease
The opportunity to receive regular medical attention from a team of experts
The chance to be one of the first people to benefit from a new method of treating your disease
Having the chance to help future patients
The risks include:
The possibility that the new treatment may not work better than the standard way of treating your disease
The possibility that the new treatment may have side effects or risks that could be worse than those of the standard method of treatment, including problems that the researchers did not anticipate before they started the trial
In randomized trials (those in which participants are randomly assigned to one treatment group or another), not having the chance to choose which treatment you will receive
The possibility that your health insurance may not cover all of the costs of participating in the trial
The need for more frequent medical tests and visits to the doctor's office than would be required if you were not participating in a clinical trial
Patients who are eligible to participate in a clinical trial must give informed consent before participating. Informed consent is a process by which the researchers conducting the trial give potential participants detailed information about what the study involves, such as the purpose of the study, the kinds of tests and treatments that will be used, and the risks and benefits of participating. This information is given to each potential participant in written form as well as in a conversation with a doctor or nurse. Those individuals who agree to participate in the study are asked to sign an informed consent document. However, signing this form does not mean that the person must stay in the trial. Participants are free to leave the trial at any time.
Informed consent does not end when the study participants sign an informed consent form. If important new information comes up during the trial - for example, if the researchers discover that the treatment they are investigating has a side effect that they did not know about - all of the study participants must be told about it so that they can make an informed decision about whether to continue to participate in the trial.