‘LEARN THE LINGO’ OF CLINICAL STUDIES
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. The clinical staff follows the protocol to monitor the patients’ health, to determine the treatment’s safety/effectiveness, and to help answer any detailed research questions you may have regarding the study.
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. These key details will assist your decision in participating or not. Our clinical staff are available to explain the details and answer any questions you have. However, this is not a contract–you may withdraw from the study at any time. Also, every study will have a different informed consent form.
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. Most trials offer compensation for your time and effort, which could be anywhere from a few hundred to a thousand dollars or more.
Every study is a little bit different.
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 what 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 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.
Who pays for clinical trials?
Pharmaceutical companies, various health organizations, and federal agencies fund clinical trials.
Will I be charged with any costs to participate?
No. Clinical trials are funded by various organizations or federal agencies. These sponsors cover the costs of the trial.
What should I think about before joining a clinical trial?
It is important to ask questions. Our team is there to provide the information and care you need, so please do not hesitate to ask any questions regarding the study. A few common questions are:
- Who is my main point of contact?
- How long will this study last?
- What is the purpose of the study?
- Has this study drug been tested before?
- Why do we believe this treatment would be effective?
- What kinds of tests and treatments are involved?
- Will this trial affect my day-to-day activities?
Can I leave a trial after it begins?
Yes. A patient has the right to choose to leave a clinical trial at any time and for whatever reason. We ask that you let our clinical staff know that you are withdrawing.
Will I ever find out if I got the placebo?
This varies by study. When patients are notified whether they received the placebo, we refer to this as “breaking the blind.” Not all studies break the blind. If the criteria allow, you will be notified once the study has reached completion.
Will my privacy be protected?
Yes. All medical records and research materials that might identify you are held confidential in accordance with the law, and are never sold or shared with third parties.
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