CLINICAL TRIAL FAQs

Clinical trials are research studies to evaluate the effects of a new treatment. They are the main way that researches find out if a new treatment, like a medication or medical device, is both safe and effective in people.

They are how we protect patients and make sure only safe and effective treatments get approved for use.

Studies usually compare a new treatment to one that’s already available or to an inactive pill (placebo) or to no treatment to see how well it works.

Trials go through different levels of testing to minimize risks while evaluating a treatment’s impact and effectiveness. Testing starts with lab work and eventually reaches studies with thousands of patients.

Every study conducted at AXCES meets the highest safety and ethical standards and is approved by an independent Institutional Review Board (IRB). The purpose of this strict approval process is to protect the rights and safety of participants. Each study is also monitored by an independent monitor on a regular basis. Participant safety is always the most important part of any clinical trial.

PRE-SCREENING (typically by phone)

After you indicate your interest in a study, we will ask you a series of basic questions to determine your potential eligibility. We’ll need to know things like your age, height, weight, race/ethnicity, and simple questions about your medical history. If you are a good fit for a trial, we will send you a consent that will give you more information.

CONSENT

If you decide you’re interested in becoming a participant in a trial, one of our team members will provide you with a copy of an Informed Consent Form (ICF), which contains information and details about the study, including how often you will see us and how long the study will last. The consent will explain what procedures may take place at visits and whether you may have access to treatments or testing through the study.

You will have an opportunity to discuss the consent form and your participation with loved ones and your doctor or medical provider before you decide to participate. Once you have reviewed the consent, you will also have plenty of opportunities to discuss your questions or concerns with our team. Once your questions have been answered, if you decide to participate, you will move to the Screening process.

SCREENING

During Screening, a member of our team will document information about who you are, your medical history, any medications you take, and any current or recent illnesses or medications. You may have a general physical exam and some basic medical tests (for example: measure your heart rate and oxygen levels, etc.) along with basic blood work to evaluate whether it is safe and appropriate for you to continue in the study. Safety is our number one priority! Once we have confirmed that your screening information makes you eligible and that it is safe for you to participate in a trial, you may move to Randomization.

RANDOMIZATION

During Randomization, a computer program may be used to randomly assign you to receive either the treatment/test or standard of care/placebo. Many studies are “double blinded,” meaning that neither you nor the medical team will know which test or treatment you receive. This is done to ensure every participant receives the same expert level of care from our team of specialists while we collect the most accurate data.

RESEARCH VISITS

Each clinical trial has a specific schedule of visits. Some trials are a single visit, and some have a combination of in-person, telemedicine, and phone visits. If your study involves more than a single visit, you will receive information about your schedule of visits over the next days and weeks so that you and your study team partner can schedule visits in a way that makes the most sense for you.

Visits sometimes include: physical examination, lab sample collection of swabs, blood, or urine, and vital signs. Some studies may ask you to complete questionnaires about your symptoms, daily activities, and when you take your medicines.

It’s very important that you are able to complete all of your study visits, both for your safety and to ensure the completeness of the study data.

Throughout the study, you will have direct access to the study team, who will check in with you regularly and can answer any questions or concerns you may have.

STUDY COMPLETION

After your final study visit, we will complete your final assessment and you will receive your final compensation. This marks the end of your trial participation. You will return to your primary care provider for any future clinical needs.

Many, including medications, medical devices (like a pacemaker), new procedures, changes to behavior (like a special diet or exercise regimen), and diagnostic tests (like COVID tests).

No, insurance is not required, and if you do participate in a study, all study visits and study-related care are free.

No, many studies enroll their participants internationally, so citizenship is not required.

Each study is different, but many offer compensation for time and travel to eligible patients. If you qualify for compensation in your study, you may receive compensation each month, after each completed visit, or after the study is completed.

Participation in a clinical trial is completely voluntary, and participants have the right to withdraw their participation at any time, no questions asked.

If you decide you’re interested in becoming a participant in a trial, one of our team members will provide you with a copy of an Informed Consent Form (ICF), which contains information and details about the study, including how often you will see us and how long the study will last. The consent will also help you understand whether there is a chance you will receive standard of care treatment/placebo.

You will have an opportunity to discuss the consent form and your participation with loved ones and your doctor or medical provider. Once you have reviewed the consent, you will also have plenty of opportunities to discuss your questions or concerns with our team, including our providers and the principal investigator.