About Clinical Research

Here are some common questions and answers about study participation.

What are clinical research studies (trials)?

Clinical trials help scientists and doctors explore whether a drug is safe and effective for people. Before any drug can be approved and made available to the public, it must go through several phases of clinical research. Individuals who participate in clinical research studies may help the next generation of cancer patients have access to more effective and potentially life-saving therapies.

Clinical trials are the main way that scientists and researchers learn about safety and effectiveness in people. Drugs that are used today are available because of volunteers in clinical trials. New drugs are studied extensively before given to patients. Once a drug passes a wide variety of testing, it will be given to people in a clinical trial.

There may be risks to joining a clinical trial. Talk to a study site or your doctor to learn more about the potential risks and benefits of an investigational drug.

What is informed consent?

Before enrolling in a clinical study, you must sign an Informed Consent Form, which your healthcare provider will review with you. The Informed Consent Form contains written information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive. You are given as much time as you need to understand and review all of the information including the ability to discuss the trial with your regular doctor, friends, and family members.

When you and your regular doctor decide you are ready for the trial, a doctor from the study will meet with you, discuss any questions or concerns you might have, and ultimately ask for your informed consent. Once the Informed Consent Form is signed, you will be able to complete any study tests necessary.

Participation in a clinical trial is completely voluntary. You may leave the trial at any moment for any reason. Leaving does not affect your medical care. If the decision is made to leave, your doctor will discuss possible treatment options with you.

What does study participation involve?

Study participation involves visiting a clinic regularly, taking or receiving an investigational drug, and undergoing tests and procedures to monitor your health (such as blood tests or physical examinations). You can still see your regular doctor, but you should let them know that you are participating in a study.

The study team will walk you through the number of visits you will make to the trial site during your participation in the study. They can also discuss supports that exist to help with your participation, including reimbursement for travel, lodging and food.

For more information on what to expect in the ReFocus study, visit the Study Overview page