Question 1

What is a clinical trial?

Accepted Answer

Clinical Trials help change the quality of life people around the world through the advancement of medicine. Clinical research studies are designed to evaluate the safety and efficacy of drugs, devices, and treatments.
To do this, researchers like us must be able to collect data from human volunteers. The information gathered from the clinical trial is used to draw conclusions about the safety and efficacy of the intervention. This information is provided to the FDA to determine it's approval for use with the general population and to be prescribed.

Question 2

What can volunteers expect while participating?

Accepted Answer

If you find out that you may qualify for a trial after a brief evaluation from our team, you can expect:

1- You will review and sign an Informed Consent form to agree to participate. You'll have a chance to ask any questions and get all the available study information before committing to participating. 
2- After that, you'll go through some initial evaluations to determine if you meet all the study criteria for entry. Every study is different and not everyone meets criteria. These criteria are meant to protect patients. These evaluations can include blood work, interviews/questionnaires, physical exams etc. A group of Scientists and Doctors as well as our team review this to make sure that it makes sense and would be safe for you to participate
3- Once we know you qualify and receive the thumbs up for you to move forward, you begin the study. You will need to come to our office at specified time points and take medication or use a device as directed. We may ask you to keep a log or diary. We will continue to monitor you throughout the study for safety and request that you report any new symptoms. All studies are different and the details of your follow up visits and the length of your participation will be discussed with you before you start.

Question 3

What is a Placebo?

Accepted Answer

A placebo is something designed to look like the real treatment but contains no active therapeutic ingredients, such as a sugar pill, saline injection, or sham procedure. Its primary purpose is to provide a baseline for comparison, allowing researchers to distinguish the genuine effects of a drug from improvements that occur due to patients’ expectations, natural disease progression, or other external factors.

Your study team will let you know if there is a chance for receiving placebo prior to starting a trial with us. In most studies, neither the research team nor volunteer knows which product was assigned. This ensures that we remain unbiased when assessing volunteers’ results. All volunteers will be treated equally, no matter what assignment the group has received.

Question 4

Why should I participate?

Accepted Answer

There are many reasons to consider participating. For one thing, many studies never make it past initial phases due to low enrollment - that means tons of potentially life changing treatments don't reach approval because there isn't enough data to report due to lack of volunteers.

Participating in a clinical trial helps not only people around the world, but also yourself.

Participants receive things like blood work, physical exams etc - all at no cost.
Participants can get access to promising new treatment before it becomes widely available and see a specialist in their condition. Clinical trials are an alternative means for care you otherwise might not have access to.

Question 5

Do I have to pay for anything or does my insurance get involved?

Accepted Answer

No. There is no cost to participate in a clinical trial with us, and insurance is not utilized.

Most of the time, we are able to offer you compensation for your time and travel during participation. Amount of compensation varies from study to study.

Question 6

What should I bring to my first appointment?

Accepted Answer

You should bring:
A valid photo ID
A complete list of all the medications you are taking, and how you take them. You may bring the actual bottles if that is easier.
Reading glasses if you need them
Copies of relevant medical records if available

Question 7

What happens if I change my mind during a study?

Accepted Answer

It is important to know that while we want all participants that begin a study with us to continue until the end for both study data and patient safety - you may exit a study at any time, for any reason.

Participation is 100% voluntary.

We would request you return to the office once more for a final safety evaluation, and to return any study medication, device, diary etc.

Please call your study coordinator for more information or if you have questions.

Question 8

Study Participant Rights

Accepted Answer

As an experimental participant you have the following rights:
1) To be told what the study is trying to find out
2) To be told what will happen to you and whether any of the procedures, drugs, or devices is different from what would be used in standard practice
3) To be told about the frequent and/or important risks, side effects, or discomforts of the things that will happen to you for research purposes
4) To be told if you can expect any benefit from participating, and, if so, what the benefit might be
5) To be told of the other choices you have and how they may be better or worse than being in the study
6) To be allowed to ask any questions concerning the study, both before agreeing to be involved and during the course of the study
7) To be told what sort of medical treatment is available if any complications arise
8) To refuse to participate at all or to change your mind about participation after the study is started. This decision will not affect your right to receive the care you would receive if you were not in the study
9) To receive a copy of the signed and dated consent form, and
10) To be free of pressure when considering whether you wish to agree to be in the study.

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