Frequently Asked Questions about Clinical Trials

A clinical research trial or study involves research using human volunteers to add to medical knowledge by testing investigational medicine, therapy, or devices on people.

Clinical trials are conducted according to very strict rules set by the Food and Drug Administration (FDA) to keep your health and privacy safe. There are also many laws which were created to keep you safe.

All clinical trials are conducted under the supervision of a qualified physician, also called an Investigator, who oversees everything related to the study to ensure that each participant is safe.

Common risks include possible side effects or undesirable effect of the investigational medication or treatment. The new treatment option may also not work or may not be better than the standard treatment.

All risks for participating in a clinical trial are provided to you in an Informed Consent.

There may be many benefits for participating in a clinical trial.  Some benefits may be receiving a new treatment which is under investigation for a disease or medical conditions. You may also be provided with medical are and frequent health check-ups as part of your participation.

All possible benefits are identified in an Informed Consent.

Before joining a clinical trial, you will be provided with information about what to expect during your voluntary participation, what the investigational medication is, as well as any possible risks or benefits. This is provided in a document called the Informed Consent Form.

The informed consent form provides you will all the details you may need to determine if you would like to volunteer in the trial. You will also have all the time you need to read this form, ask questions to our experienced research professionals, and can even take the informed consent home to discuss with your family. 

All clinical trials have a set of criteria or requirements. These criteria or can be based on things like age, gender, current medical conditions, current medication, and more. 

Each trial identifies which criteria a volunteer must have and what criteria a volunteer may not have in order to participate. Meeting or not meeting these criteria determines who may participate in a clinical trial.

Yes. Participation in a clinical trial is voluntary. Volunteers may withdraw from a clinical trial at any time.

You may find additional information in these websites:

• ClinicalTrials.gov - You can find more information about clinical trials.
• Food and Drug Administration (FDA) - You can find regulations and additional information about clinical trials.