Are clinical trials safe?
Several levels of safeguards are in place to help protect the patients who participate in clinical trials. While there are risks with any study and any treatment, there are safeguards in place to reduce this risk as much as possible.
In order to join a trial, each patient must first read and sign an informed consent document. This document explains:
- Your rights (including the right to leave the trial at any time for any reason),
- The purpose of the trial,
- The procedures involved,
- A guarantee that your information will remain confidential,
- And, the risks and benefits of participating.
The Food and Drug Administration (FDA)
The FDA's job is to ensure that medical treatments are safe and effective for patients to use. The FDA monitors most clinical trials to protect the rights of patients and to ensure that the trial is being run according to plan.
Institutional Review Board (IRB)
Each hospital or site that participates in a trial has an IRB that reviews, monitors and approves the plan for the clinical trial. The IRB is typcially made up of healthcare professionals, clergy members and other individuals from within the community The role of the IRB is to:
- Review the plan for the trial to ensure patient's safety,
- Continues to review the trial on an ongoing basis,
- Stop a trial if it appears to cause unexpected side effects for patients or if there is clear evidence that the new treatment is causing harm to patients.
Data Safety Monitoring Board (DSMB)
The DSMB is an independent committee made up of statisticians, physicians and other scientists. The role of the DSMB is to ensure the safety of patients and to review all trial results. If patients experience unexpected or severe side effects, the DSMB may stop the trial.