Safety of Clinical Trial Volunteers

The safety of volunteers and patients is always our highest priority at PPD. The same ethical and legal codes that govern medical practice apply also to clinical trials. In addition, most clinical research is regulated by governments, with built-in safeguards to protect the clinical trial volunteers.

Clinical trials must be approved and monitored by institutional review boards (IRBs) or independent ethics committees (IECs) to make sure the risks are as low as possible and are worth any potential benefits. The boards are comprised of physicians, community advocates and others who are responsible for ensuring that a clinical trial is ethical and the rights of volunteers are protected.

Clinical trials follow carefully controlled protocols, which detail how researchers must conduct them. As a clinical trial progresses, researchers report the results of the trial at scientific meetings and in medical journals as well as to various government agencies. The names of individual volunteers remain private.

Volunteers have the right to refuse treatment at any point during the clinical trial and leave at any time and for any reason.

Risks Related to Clinical Trials

All clinical trials involve some form of risk. However, the risks are always evaluated closely.

The specific risks related to any clinical trial are described during the informed consent process. Informed consent recognizes a patient’s need to know about a procedure, surgery or treatment before he or she decides to have it.