What is a clinical trial?

A clinical trial, also called research study, is a voluntary interventional study conducted in people and designed to test the safety or effectiveness of drugs, vaccines, and other therapies, or new ways of using existing treatments.

Are clinical trials safe?

Before a clinical trial can start, it must be approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC) to ensure that appropriate steps are taken to protect the rights of participants. An IRB or IEC is a committee of doctors, data experts, community advocates, and others who help ensure that a trial is done in an ethical way and the rights of participants are protected. Even so, there are risks to participating in any clinical trial, which will be outlined in the informed consent process.

Each trial follows a carefully controlled plan (protocol) that explains what researchers will do during the trial.

What is an investigational drug?

An investigational drug is not approved for use or by prescription from doctors for the condition being studied. Investigational drugs are tested during clinical trials to see if they are safe and effective for a specific medical condition and/or group of people.

Will my privacy and confidentiality be protected?

The information you provide will not be shared with anyone who is not directly associated with the clinical trial in which you participate without your permission, except as required by law or as outlined in the informed consent process.

Can I change my mind about participating in a clinical trial after I enroll?

Yes, your participation in any clinical trial is completely voluntary. If you decide to participate in a clinical research study, you are always free to withdraw at any time, for any reason, without any effect on your medical care.

Who will oversee my care in a clinical trial? Can I continue to see my primary care physician?

Your primary care physician does not have to give you permission to participate. Feel free to talk to your doctor about participating in the clinical research study. The study team will oversee your participation in the clinical trial. You can continue to see your primary care physician and you should talk with them about participating in the clinical trial. Your primary care physician does not have to give you permission to participate. With your permission, the study doctor will keep your primary care physician updated about your condition during the clinical research study.

Does participating in a clinical trial cost anything?

All study-related procedures and the study drug (investigational drug or placebo) will be provided at no cost. Transportation assistance may also be available. The study team can provide more information.

Will I be compensated for participating in a clinical trial?

Depending on the clinical trial, you may be compensated for your time and, in some instances, reimbursed for transportation expenses, but not in all cases. The study team can provide more information.

Who oversees clinical trials?

To help ensure that a clinical research study is ethical and that participants’ rights are protected, Independent Review Boards (IRBs), Independent Ethics Committees (IECs), and regulatory agencies like the Food and Drug Administration (FDA) review study protocols and oversee clinical trials to help ensure they adhere to applicable law.