Accurate records and all appointments must be kept. If the patient has problems or is not benefiting from the trial the medical team may suggest leaving the trial or the patient may leave for their own reasons. Patients should be informed about the treatment and risks. Also a comparison of treatment lengths. Many times the treatment used in the trial is available at no cost to the patient.
Informed consent is required for trial participation.
Informed consent means the patient has been informed of the expected risks and benefits of the trial and has been told about the nature of the treatment and what tests and examinations are to be expected. For the patient to give informed consent these must be made clear before signing the consent form. The form should be read carefully. It is important to remember that even if the patient signs the informed consent form the patient may, at any time, quit the trial. Once the patient makes the decision to join a trial they will be randomly assigned to a group either receiving the standard treatment or the new treatment being studied.