Clinical Trials: Safety

---

How are people who are involved in clinical trials protected?

Clinical trials are designed keeping in mind both the importance of the purpose of the study as well as the well-being of the study participants. Researchers follow strict ethical and scientific principles in order to make sure that patients are protected and valid results are produced. In order to make sure all researchers involved with the study are conducting the study according to these principles, a plan of how the study will be run called a protocol is written.

The protocol is written by the study's investigator, usually a doctor. In the protocol details of what will be done in the study and why are outlined. These details will include the expected number of participants, the type of treatment they will receive, as well as the types of medical test they will undergo and how often. All researchers taking part in the study will use the same protocol.

In order to ensure patient safety, the protocol must be reviewed and approved by the organization that sponsors the study as well as an Institutional Review Board. This board consists of people with a variety of backgrounds including clergy, health professionals and general consumers. In the review of the protocol, the board tries to ensure that participants in the study will not be exposed to unreasonable or unethical risks.

Related links

How is a Clinical Trial Planned and Carried Out?

Protections for Participants of Clinical Trials

What Happens Before and During the Trial

FDA Guidelines for Protection of Trial Subjects

Are there risks in clinical trials?

The process of evaluating new treatments can involve some risk. All drugs used in clinical trials have been extensively tested in laboratory experiments. However, some side effects do not become apparent until the treatments are given to humans. Side effects can vary from patient to patient. It is important to remember that clinical trials can carry unknown dangers as well as possible benefits.

The progress of patients in clinical trials is constantly monitored. Periodic reviews of test results and other statistics are carried out while the trial is underway. If, at any time, a new treatment is found to be harmful to the study participants, the trial will be terminated.

Related links

Protecting Participants of Clinical Trials

The content on this page was written by Dr. Marc Engelsgjerd and Michael D'Agostino of Veritas Medicine