Clinical Studies - FAQ & Glossary

At Biofortis US, our mission is to advance the science of chronic disease prevention by designing and conducting clinical trials. In doing so we hope to contribute to the development of safe and effective ways to help people live longer, healthier lives.

FAQ

GLOSSARY

 

What is a clinical study?
A clinical study is a carefully planned experiment or protocol, using real people to answer specific questions about a new drug therapy, medical device or nutritional product. Some of the purposes of clinical studies are to test how safe and effective a new product is and to evaluate potential side effects.

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Who participates in clinical studies?
Every day people participate in clinical studies, from children to college students, working adults and the elderly. You don’t have to be sick or have chronic health issues. Anyone can participate in a study as long as they meet all of the inclusion and none of the exclusion criteria for a particular study. Every study has a different goal therefore we are always looking for volunteers with different characteristics. If you don’t qualify for any of our current studies, in the future you may qualify for another. If you join our mailing list, we can notify you when a study for which you may be eligible becomes available. Join our mailing list now.

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Why should I participate?
Your participation can help promote advances in science and medicine. By volunteering you will be able to understand your health better while improving the future for others in managing their health and/or diseases. Other benefits of participating may include free assessment of your health by a trained professional, learning more about your condition, learning more about nutrition and how it affects your health and how to reduce risk factors to stay healthier.

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If I choose to participate, what happens during the study and how long does it last?
How long a study lasts and what happens during participation depends on the type of study. Some studies last only a few weeks while others can last for several months. For example, some studies request that you visit the clinic once a week to take measurements or to conduct tests while some require you come in once every other week. Some studies look at new blood pressure medications, so your blood pressure and heart rate may be taken at each visit. Other studies test cholesterol lowering drugs, so your blood may be drawn at each visit to measure your cholesterol and triglycerides. When you inquire about a study that you’re interested in, a Biofortis representative will inform you of how long it will take and what is involved. There are never any surprises.

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Will I be taking the study product or a placebo (control)?
When participants enroll in a study and they meet all the inclusion and exclusion criteria, they are then randomized into treatment groups. In some studies, no one knows what treatment group a particular participant is assigned to including the clinic staff until the study is completed. This ensures that there is no bias in the evaluation of the study intervention. This type of study is referred to as a double-blind study, meaning that both the clinical personnel and the participants don’t know what they are receiving.

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What is the control?
The control group is the group in a study that doesn’t receive the experimental treatment but instead receives a placebo or a standard treatment for the disease or condition in question. The control group is very important in clinical studies because it is what the treatment group is measured against.

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What is informed consent?
Informed consent is a process in which the person who would like to volunteer for a clinical study is informed about the nature of the study so that he/she can decide whether or not to participate. During this time, the volunteer is told how the study product will be used, how long the study will take, any testing procedures that will be performed, as well as the known risks and benefits involved. In addition, volunteers will learn how the safety of taking the study product will be monitored during the study, and who to call if problems or questions should arise. If the volunteer decides that he/she wants to enroll in the study, he/she will then sign the informed consent document. The document describes the rights of the participant, the details of the study including its duration, and all known risks and benefits.

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If I participate in a study, can I stop at anytime?
Yes. The study participant can decide to withdraw from the study at any time for any reason without consequence. In addition, the study physicians can also withdraw a study participant if they feel that the treatment involved is no longer in the best interest of the study participant.

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How do I enroll in a study?

Current Enrolling Studies

For more information on enrolling in one of our clinical studies, please do either of the following:

Enroll now. Upon receipt, a Biofortis representative will call you or send you additional information.
Call (630) 617-2000 to speak with our associates who can answer your questions about volunteering in a clinical study. We welcome the opportunity to speak with you about current and upcoming studies.

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GLOSSARY


Clinical Investigator or Study Physician
A medical researcher in charge of carrying out a clinical study or protocol.

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Clinical Study or Trial
A carefully designed study to test the effects of a new food additive or medication, medical treatment, or device on a group of volunteers. They are used to determine whether new drugs or treatments are safe and/or effective.

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Control Group
The control group is the standard to which the experimental observations from the study are measured against. In a controlled study, one group receives the treatment (treatment group) and the other receives the control (control group) which can be a placebo or a standard treatment for a disease.

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Crossover Study
A type of clinical trial in which the study subjects receive all the treatments in the study in a random order. With this type of study, every subject serves as his or her own control.

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Double-Blind Study
Term used to describe a study in which both the investigator and the participant are unaware of which treatment the participant is receiving. Double blind trials are thought to produce objective results, since the expectations of the researcher and the participant about the experimental treatment (such as a food additive) do not affect the outcome.

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Food and Drug Administration (FDA)
A government agency that enforces laws regarding the manufacturing, testing, and use of drugs and medical devices. The FDA must approve a drug for marketing before it can become readily available to the medical community and the public.

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Inclusion and Exclusion Criteria
Medical standards determining whether a person may or may not be allowed to enter a clinical study. These criteria may be based on such factors as age, gender, the type and stage of a disease, previous medication use, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

Informed Consent
A discussion between clinical investigators and persons interested in participating in the study of procedures, benefits, and risks of a clinical study. The FDA requires that volunteers sign an informed consent form (approved by the IRB) before entering a study. Institutional Review Board (IRB) A group of healthcare professionals as well as members of the local community. The IRB carefully reviews study activities as it is responsible for protecting the safety and the rights of volunteers.

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Placebo
A "sugar pill" or any dummy medication or treatment.

Protocol
A study plan on which the conduct of a clinical trial is based.

Randomization
A method based on chance by which study participants are assigned to a treatment group.

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