Clinical Trial Risks and Safety Measures: What is Involved?

Clinical trials are an important (and sometimes the only) way to test a new medication or treatment. However, participants must be aware of the risks and safety measures steps during a clinical trial.

Possible risks include:

• Participants may experience unpleasant, serious, or even life-threatening side effects of the drug or treatment being studied.

• The treatment may not work.

• The requirements of the study may be more than the participant thought. Every clinical trial has a protocol, which is the plan on which the entire study is based. The protocol describes exactly what the participants must do during the trial such as how often they need to see the research staff, how much of the drug they need to take, what other procedures they must follow, and how long the trial will last. Sometimes, particularly for participants who are not in good health, these activities take up a good deal of time and attention.

Safety measures help to minimize risks:

• All clinical trials that involve human participants in the United States are approved and monitored by an Institutional Review Board (IRB). This is a group of doctors, researchers, community advocates, and others who ensure the ethical nature of the trial and make sure that the rights of the study participants are protected.

• The IRB reviews all study-related documents such as the protocol, participant recruitment announcements, and consent forms.

• What Are the Possible Benefits of Participating in a Clinical Trial?
• Medical Errors and How to Avoid Them
• What is Post-Operative Care?