What is a clinical trial?

A clinical trial is generally considered to be a health-related research study in human beings that follows a pre-defined plan. The UCSF Memory and Aging Center conducts both observational and interventional types of clinical trials.

• Observational studies are used to follow people who may already be receiving treatment for an illness while measuring their outcomes. These studies rely upon a more natural setting as participants select their treatment. This approach is often used when interventional studies would be unethical or impractical (such as in the case of a rare disease).
• Interventional studies test promising treatments in a controlled environment. In these studies, the investigator assigns participants to particular treatment groups in order to measure and compare their outcomes at the end of the trial.

New treatments cannot be widely used until they have been shown to work safely in patients, and clinical trials are the standard used to judge these treatments safe and effective.

What should I expect?

Before you or your loved one join a trial, your doctor should talk to you about what it's like to be in a trial describing the pros and cons of participating. If you are interested, someone from the clinical trial staff will explain the details of the study, including risks and benefits and your rights as a participant, including your right to withdraw from the study at any point. Once all your questions have been answered, they will ask you to sign an informed consent to participate. After that, the number of visits and treatments are determined by the study plan.

The benefits of participating

Well-designed and well-executed clinical trials are the best approach for eligible participants to:

• Play an active role in your 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.
• Help others by contributing to medical research.

The risks of participating

There are risks to clinical trials.

• The experimental treatment may not be effective for the participant.
• There may be unpleasant or serious side effects to experimental treatment.
• The protocol may require more time than a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.