CLINICAL TRIALS

Risks and side effects exist with any medical treatment, whether it is a standard treatment or a clinical trial. Clinical trials have many safeguards to protect the health and safety of the patients

• Treatments are carefully studied in laboratories before they are used with patients.

• Any research involving patients must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors, administrators, ethics specialists, and members of the general public. The IRB reviews every clinical trial to protect the rights and welfare of the patients.

• Patients considering a clinical trial receive verbal and written information about the trial, including information about any known risks or side effects.

• Patients must sign a consent form before entering a trial.

• Patients have the right to stop participating in a trial at any time.

• Patients are carefully monitored by exams, blood tests, x-rays, and phone calls. This means that any changes in a patient's condition are promptly detected and examined.

• Data on a patient's condition are constantly checked by the clinical trial sponsor.

• Patients are informed of new information that emerges during a clinical trial, such as when data accumulate about adverse effects or new, more convenient dosing schedules.