What is a clinical trial?
Clinical trials are research studies performed in people that are aimed at evaluating a medical intervention. They are the primary way that researchers find out if a new treatment, like a new drug or medical device is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

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Who can participate in a clinical trial?
Clinical trials have standards outlining who can participate called eligibility criteria. The clinical research coordinator you meet with will review all of these criteria to see if the clinical trial you are interested in is right for you.

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Is a clinical trial guaranteed to help me?
Clinical trials are designed to determine if a treatment works, if it works better than other treatments and/or if it has side effects. They also provide important information on the cost-effectiveness of a treatment, the clinical value of a diagnostic test and how a treatment improves quality of life. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do notprovide extended or complete health care, nor do they guarantee results.

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What if I don’t want to take part anymore?
Participants may withdraw from a study at any time, even if the study is not over. Ending participation early will not impact your ability to receive healthcare.
 

Do I get paid to take part?
No. You do not get paid to participate in a clinical trial, however, some trials do provide compensation per study visit for travel, childcare etc. Your study coordinator will review this with you.
 

How long is a clinical trial?
The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll.
 

How do I get started?
Contact us for more information.

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How do I learn the risks?
Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study.
 

Does participation in the study potentially put me at higher risk for COVID-19 infection?
The risks related to study participation will be outlined in the informed consent form. Your study doctor will follow his/her standard medical decision-making process as well as follow any local guidance(s) available when deciding whether your participation and potential treatment is in your best interest.
 

How will my participation in the clinical trial be impacted in the event that at some point during my study participation, I test positive or I am being quarantined for suspected symptoms of COVID-19?
During the study, if you have tested positive or are under quarantine for suspected disease, please notify your study doctor right away. The study doctor will ask you about your symptoms, diagnosis and any treatment you may be receiving.

During your quarantine period your study visits will continue remotely until further notice. Your study doctor will discuss with the study Sponsor about what other steps should be taken.
 

What happens if I cannot attend an onsite study visit due to COVID-19?
Many studies have a remote study visit plan to accommodate for COVID-19. Your study coordinator will talk to you about this option.
 

Please explain what I should expect when I arrive onsite. Will the site have different requirements than in previous visits? Do I need to take any new precautions?
The study doctor and staff will continue to follow local guidelines and practices to implement and ensure safety precautions and measures are in place, in order to protect both staff and patients.

When you arrive on site you will text or email the study coordinator you’ve been corresponding with to let them know you’ve arrived. Please wait in your car until you are asked to approach the main doors. You and any persons accompanying you must be wearing a mask to enter the building. You will be provided with hand sanitizer and you will have your temperature taken at the door. The research staff will be in frequent communication with you, in-particular before each study visit, to ensure you know what to expect upon your arrival and during your visit. They will let you know if anything has changed since your last visit, so that you know what to expect.

Please do not hesitate to raise any questions or concerns to our clinical coordinators.