Laboratory research establishes how best to use the new methods in people, safely and effectively. The IRB is a board of scientists and lay people not connected with the trial, who decide whether the trial is ethical. The IRB is authorized to review, require changes to, approve or disapprove studies. Patients who volunteer for trials can withdraw at any time without any effect on how they would be treated in the future. Trials are monitored and if obvious problems or success are noted, changes are made.
Cost is an important consideration for a patient thinking about entering a clinical trial.
Clinical trials that test a treatment may require clinic or hospital visits, X-rays, blood tests or other medical procedures. Some studies may have a sponsor that pays some or all of the costs. Sponsors could be the federal government or the company that makes the new drug or device. Health insurance and managed care providers do not always cover all patient costs in a clinical trial. Before making any decisions, you should call your insurance company to learn what its coverage would be for a specific clinical trial.