What else should a participant in a clinical trial consider?

You should consider whether you want to empower someone you trust to make health decisions for you if you become sick. This is very important if you choose to participate in a study that changes your regular medication routine, and you and the researchers are unsure about how your body will react. For example, if your thinking becomes impaired, you might make a decision that you would not make if you were thinking clearly. In this case, you may want someone you trust to make a decision for you.

You are not always required to name someone else to make decisions if you become impaired. If you wish to do so, however, speak to the researcher to make sure he or she understands what you want; you may also want to ask what kind of paperwork is required to ensure that your representative will be contacted.

What are the benefits and risks of participating in a clinical trial?

Clinical research can involve risk, but it is important to remember that routine medical care also involves risk. It is important that you weigh the risks and benefits of participating in research before enrolling. When thinking about risk, consider two important questions:

1. What is the chance that the study will cause me harm?
2. If there is a chance of harm, how much harm could I experience?

If you are interested in participating in a study, ask the researchers any questions that will help you decide whether to participate. Taking time to share your concerns will help you feel safe if you do decide to volunteer. (You can find sample questions here) It may be helpful to involve close family members, your doctors, or friends in this decision-making process.

Benefits of a clinical trial

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Research-related care or medicine at no cost.
• The opportunity to learn more about an illness and how to take care of it.
• Help others by contributing to medical research.

Risks of a clinical trial

The nature of the risks depends on the kind of study. Often, clinical studies pose the risk of only minor discomfort that lasts for a short time. For example, in some mental health studies, participants take psychological tests; this is obviously a different kind of risk from undergoing surgery as part of a study. A participant in a study requiring surgery may risk greater complications. Risk can occur in many different ways, and it is important to speak with the research team to understand the risks in a particular study.

Keep in mind that all research sites are required to review their studies for any possible harm, and to share any potential risks with study volunteers.

Risks to clinical trials include:

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment. The treatment you receive may cause side effects that are serious enough to require medical attention.
• The experimental treatment may not be effective for the participant.
• You may enroll in the study hoping to receive a new treatment, but you may be randomly assigned to receive a standard treatment or placebo (inactive pill).
• Whether a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment, may not work at all, or may be harmful.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.