Frequently Asked Questions – FAQ
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FAQS
‘LEARN THE LINGO’ OF CLINICAL STUDIES
Protocol
A protocol is the blueprint of a study. Each study has a protocol that plans out the trial step by step with the criteria clearly stated, including medical qualifications of who can and cannot join the study, the schedule of procedures and dosages, and the study length of time. It is designed to protect the health of all participants.
Informed Consent
The informed consent form (sometimes called ICF) is the general overview of a specific study that provides you with important information such as the purpose, duration, compensation, and possible risks and expectations you should have, if you want to participate in that study
Placebo-Controlled
The term “placebo-controlled” indicates that this study includes a placebo. In other words, there is a chance that the medication you receive is inactive and not an actual treatment. It is used as a control group to compare the real study’s drug effects. Your symptoms may come from the actual drug, or your perception of what you received if you got the placebo. Therefore, “placebo controlled” maintains integrity of the study.
Why should I join a clinical trial?
Who can join a clinical trial?
Almost anyone can participate in a clinical trial. You can participate in clinical trials to advance medical research—regardless of your age, health, ethnicity or background. There is no insurance required, nor any proof of legal status or citizenship.
Many trials are for healthy volunteers. These include most vaccine trials. Others are looking for people with specific illnesses or medical conditions, such a type 2 diabetes. These potentially offer participants the chance at access to new investigational therapies, well before they are approved for the general public.
Clinical research volunteers are paving the way by contributing in trials to help bring novel medicines to the US and the world.
Can I get compensated for study participation?
Yes. Every study is a little bit different.
Most trials offer compensation for your time and effort, which could be anywhere from a few hundred to a thousand dollars or more.
The compensation you receive is approved by an independent ethics board, and is relative to what is required of you in that trial—including the length and number of study visits. The compensation is detailed in the informed consent document you will receive at your first study visit.
When you speak with our Patient Enrollment Specialists, please feel free to discuss the compensation with them. We appreciate the sacrifice of your time and effort entailed in study participation, and want to be upfront with you about compensation.
What does participation in a study entail?
It varies by study. Studies typically require you to come to the clinic a few times, complete e-diaries, and/or speak with clinicians on the phone. The majority of our trials are conducted in outpatient clinics—that means that no overnight stay is needed for most of the studies. Most visits are similar to what you would experience at your regular care visits to your doctor, such as a physical exam, vitals, medical history, blood/urine sample.
What are the potential risks or benefits?
It varies by study. The ethics and laws that govern medical practice also apply to clinical studies, and we adhere to these strict standards. However, studies, by nature, involve investigational products that might be ineffective or cause side effects.
Clinical studies are overseen by the U.S. Food and Drug Administration (FDA). Clinical studies also follow strict protocols that we adhere to, and they are reviewed by Institutional Review Boards (IRBs)—a board of highly qualified individuals who are dedicated to ensuring patients’ rights are protected.
Each participant goes through an informed consent process that explains in detail each step of the trial. Our team will help clarify information regarding the specific medicine that is being studied, the number of required doctor or clinic visits, potential side effects and many other aspects of the study and your participation. You are encouraged to ask any and all questions throughout the process.
Am I eligible to join a clinical trial?
Each clinical trial is provided with a protocol – which are the guidelines for a study. There are trials that seek patients with a specific medical condition and others that seek healthy participants. Each study is different. The protocol provides inclusion and exclusion criteria depending on various factors that allow us to determine your eligibility or ineligibility for a specific trial.