Glossary - Your Guide to Clinical Trials
Reading about medical research can be confusing. This is why we have created an overview of the most important clinical trial terms.
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect.
A
Endometriosis is a common health problem for women worldwide. Researchers think that at least 11% of women, or more than 6 ½ million women in the United States, are living with endometriosis. Across the US, there are multiple clinical trials researching new treatments, diagnostics, and cures for endometriosis.
C
The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[4] and veterinary products.
D
Hot flashes tend to be most frequent in the two years after menopause. Most women continue to have hot flashes anywhere from 4-10 years after menopause. But most of these will decrease in frequency and severity. Clinical research has made it its mission to find treatments and cures for hot flashes and menopausal symptoms to increase quality of life.
Hypertension, also known as high blood pressure, is a common condition worldwide. Nearly half of adults in the United States (45%) have hypertension defined as a systolic blood pressure or a diastolic blood pressure or are taking medication for hypertension. This is why clinical research is essential to find treatments and diagnostics to make a difference for people living with high blood pressure.
E
If you’re thinking of taking part in a clinical trial, you will likely come across an informed consent form. The informed consent form gives you all the information about the purpose of the clinical trial, benefits and potential risks, which procedures are involved in the trial, your rights and that taking part in research is absolutely your choice. It will help you to better understand what to expect when you participate in this specific trial.
F
About 40% of people aged 65 or older have age associated memory impairment—in the United States, about 16 million people. Only about 1% of them will progress to dementia each year. Clinical research is constantly working on finding new diagnostics and treatments to improve quality of life for people living with memory impairment.
H
A protocol is a central information source and describes the rules of the clinical trial. First, it states why a specific question is researched and how the research team will answer the question; second, it includes information on the specific procedures, which medications will be used (if any), which data analysis methods will be used, possible benefits and risks and possible adverse events, and third, it also tells you who can and cannot participate. A protocol also tells you how the research team will protect the health and wellbeing of the participants.
I
M
A serious adverse event is any untoward occurrence occurring in a clinical trial or a performance evaluation subject to authorisation which has led, could have led or could lead, directly or indirectly, to the death of a subject, a user or another person or to a serious deterioration in their state of health.
P
Clinical trials are so important because they’re the only way to see if new drugs, new combinations of drugs, new treatment methods, medical innovations, diagnostic methods or medical devices actually work for a specific health condition and are safe to use. Without clinical trials, there are no advancements in medicine.
The FDA (Food and Drug Administration) regulates clinical trials and demands that clinical trials must be conducted before a new drug, medical device diagnostic methods or other treatments can be marketed in the United States.
If you wish to volunteer in a clinical trial, you agree to participate and test new drugs, new treatment methods, new diagnostic methods or new medical devices, for example. Important: nobody can force you to participate in a clinical trial and you can drop out at any time, even when you’re already enrolled in a clinical trial.
You should consider the following questions when thinking about joining a clinical trial:
- Will the research help me?
- What are the risks involved?
- What do I need to do? E.g. how many doctor visits are involved?
- Do I have to change something in my lifestyle?
- Will I be compensated?
This is a tough question to answer in a general way, because expectations differ from study to study. Some clinical trials expect that you take some supplements and visit the research site closest to you every month. Others expect that you go to the gym 3-4 times per week, others expect that you change your diet.
Generally, you should ask the clinical trial team what the time commitment is for the clinical trial you’re interested in, and what is expected from you.
When you expressed interest in joining a clinical trial via Citruslabs, our algorithm checks if you qualify for any of the clinical trials we are working with and matches you with the closest research site (usually up to 25 miles away from you - in highly populated areas usually up to 10 miles).
The research team from the research site will then give you a call to tell you more about the clinical trial and also ask you some additional questions. If everything works for you, they will invite you to an on-site screening visit at their location. Often these visits include blood pressure measurement, heart rate measurement, urine analysis, and maybe some blood work. All this is free of charge for you.
Once you passed the screening, the site will invite you to join the clinical trial and needs you to sign an informed consent form to do this. The informed consent form gives you all the information about the purpose of the clinical trial, benefits and potential risks, and helps you to better understand what to expect when you participate in this specific trial.
Benefits and risks differ from trial to trial and you should always talk to the research team before you decide to participate in a clinical trial to fully understand specific benefits and risks.
Generally, clinical trials may give you access to the best possible treatment for your specific health condition that would otherwise not be available to you. You will also receive attention from a care team consisting of nurses, doctors, and other medical staff, that you would otherwise not get.
And, you will help not only research to improve or even find new treatments but as a result, you will also help millions of other people who may be benefitting from these (often live-saving) new treatments in the future as well.
General risks always include possible side effects - that sometimes even need medical attention. If you are part of a randomized trial, this could also mean that there is a placebo (inactive treatment) involved and you could actually get the placebo instead of the real treatment. Or, the trial simply expects too much time commitment from your side.
A protocol is a central information source and describes the rules of the clinical trial. First, it states why a specific question is researched and how the research team will answer the question; second, it includes information on the specific procedures, which medications will be used (if any), which data analysis methods will be used, possible benefits and risks and possible adverse events, and third, it also tells you who can and cannot participate. A protocol also tells you how the research team will protect the health and wellbeing of the participants.
If you’re thinking of taking part in a clinical trial, you will likely come across an informed consent form. The informed consent form gives you all the information about the purpose of the clinical trial, benefits and potential risks, which procedures are involved in the trial, your rights and that taking part in research is absolutely your choice. It will help you to better understand what to expect when you participate in this specific trial.
When you express interest in participating in a clinical trial, you have to undergo a screening process in order to determine if you actually qualify to participate in the trial. There is a protocol that sets the rules around who can and who cannot participate.
First, you will undergo a pre-screening that usually happens via phone. Here, the trial staff will ask you specific questions about your demographic information and medical history. They will also provide you with more information on the trial. If the clinical trial staff determined that you meet the criteria that are set by the protocol, you will be invited for an on-site screening visit.
At the on-site screening visit, you will go to the clinical trial location (usually in your area). The clinical trial staff will again give you more information on the trial and a qualified doctor will usually perform a physical examination as well and review your medical history.
In some cases, taking part in a clinical trial will not cost you or your insurance company anything. Especially for people in the US, this is good news! However, other studies may bill your insurance company for drugs, the services they provide or the devices that they may hand out to you. There is the possibility that your insurance company may not pay for some or all of the charges and you may receive a bill by the researchers for this. Due to this, it is very important that you look carefully at the informed consent form which will describe any costs to you in great detail. If the information is not clear to you, you should definitely ask a research team to explain the costs to you before you agree to participate in the trial and sign the consent form.
There are several levels of safeguards in place to protect participants in clinical trials. Nevertheless, there are still risks involved in taking part in a clinical trial, which should be disclosed to you during the informed consent process.
There are three basic principles as the basis for research that involved humans:
1. Respect for persons: all people should be respected and have the right to choose what treatments they receive.
2. Beneficence: people should be protected from harm by maximizing benefits and minimizing risks.
3. Justice: it must be ensured that all people share the benefits and burden of research equally.
There is also an institutional review board (IRB) in place for every clinical trial, which is protecting the welfare of the people who participate in a clinical trial and make sure that those trials also comply with federal laws. Every protocol (which is the backbone of a clinical trial) must be approved by an IRB.
R
Clinical trials are so important because they’re the only way to see if new drugs, new combinations of drugs, new treatment methods, medical innovations, diagnostic methods or medical devices actually work for a specific health condition and are safe to use. Without clinical trials, there are no advancements in medicine.
The FDA (Food and Drug Administration) regulates clinical trials and demands that clinical trials must be conducted before a new drug, medical device diagnostic methods or other treatments can be marketed in the United States.
If you wish to volunteer in a clinical trial, you agree to participate and test new drugs, new treatment methods, new diagnostic methods or new medical devices, for example. Important: nobody can force you to participate in a clinical trial and you can drop out at any time, even when you’re already enrolled in a clinical trial.
You should consider the following questions when thinking about joining a clinical trial:
- Will the research help me?
- What are the risks involved?
- What do I need to do? E.g. how many doctor visits are involved?
- Do I have to change something in my lifestyle?
- Will I be compensated?
This is a tough question to answer in a general way, because expectations differ from study to study. Some clinical trials expect that you take some supplements and visit the research site closest to you every month. Others expect that you go to the gym 3-4 times per week, others expect that you change your diet.
Generally, you should ask the clinical trial team what the time commitment is for the clinical trial you’re interested in, and what is expected from you.
When you expressed interest in joining a clinical trial via Citruslabs, our algorithm checks if you qualify for any of the clinical trials we are working with and matches you with the closest research site (usually up to 25 miles away from you - in highly populated areas usually up to 10 miles).
The research team from the research site will then give you a call to tell you more about the clinical trial and also ask you some additional questions. If everything works for you, they will invite you to an on-site screening visit at their location. Often these visits include blood pressure measurement, heart rate measurement, urine analysis, and maybe some blood work. All this is free of charge for you.
Once you passed the screening, the site will invite you to join the clinical trial and needs you to sign an informed consent form to do this. The informed consent form gives you all the information about the purpose of the clinical trial, benefits and potential risks, and helps you to better understand what to expect when you participate in this specific trial.
Benefits and risks differ from trial to trial and you should always talk to the research team before you decide to participate in a clinical trial to fully understand specific benefits and risks.
Generally, clinical trials may give you access to the best possible treatment for your specific health condition that would otherwise not be available to you. You will also receive attention from a care team consisting of nurses, doctors, and other medical staff, that you would otherwise not get.
And, you will help not only research to improve or even find new treatments but as a result, you will also help millions of other people who may be benefitting from these (often live-saving) new treatments in the future as well.
General risks always include possible side effects - that sometimes even need medical attention. If you are part of a randomized trial, this could also mean that there is a placebo (inactive treatment) involved and you could actually get the placebo instead of the real treatment. Or, the trial simply expects too much time commitment from your side.
A protocol is a central information source and describes the rules of the clinical trial. First, it states why a specific question is researched and how the research team will answer the question; second, it includes information on the specific procedures, which medications will be used (if any), which data analysis methods will be used, possible benefits and risks and possible adverse events, and third, it also tells you who can and cannot participate. A protocol also tells you how the research team will protect the health and wellbeing of the participants.
If you’re thinking of taking part in a clinical trial, you will likely come across an informed consent form. The informed consent form gives you all the information about the purpose of the clinical trial, benefits and potential risks, which procedures are involved in the trial, your rights and that taking part in research is absolutely your choice. It will help you to better understand what to expect when you participate in this specific trial.
When you express interest in participating in a clinical trial, you have to undergo a screening process in order to determine if you actually qualify to participate in the trial. There is a protocol that sets the rules around who can and who cannot participate.
First, you will undergo a pre-screening that usually happens via phone. Here, the trial staff will ask you specific questions about your demographic information and medical history. They will also provide you with more information on the trial. If the clinical trial staff determined that you meet the criteria that are set by the protocol, you will be invited for an on-site screening visit.
At the on-site screening visit, you will go to the clinical trial location (usually in your area). The clinical trial staff will again give you more information on the trial and a qualified doctor will usually perform a physical examination as well and review your medical history.
In some cases, taking part in a clinical trial will not cost you or your insurance company anything. Especially for people in the US, this is good news! However, other studies may bill your insurance company for drugs, the services they provide or the devices that they may hand out to you. There is the possibility that your insurance company may not pay for some or all of the charges and you may receive a bill by the researchers for this. Due to this, it is very important that you look carefully at the informed consent form which will describe any costs to you in great detail. If the information is not clear to you, you should definitely ask a research team to explain the costs to you before you agree to participate in the trial and sign the consent form.
There are several levels of safeguards in place to protect participants in clinical trials. Nevertheless, there are still risks involved in taking part in a clinical trial, which should be disclosed to you during the informed consent process.
There are three basic principles as the basis for research that involved humans:
1. Respect for persons: all people should be respected and have the right to choose what treatments they receive.
2. Beneficence: people should be protected from harm by maximizing benefits and minimizing risks.
3. Justice: it must be ensured that all people share the benefits and burden of research equally.
There is also an institutional review board (IRB) in place for every clinical trial, which is protecting the welfare of the people who participate in a clinical trial and make sure that those trials also comply with federal laws. Every protocol (which is the backbone of a clinical trial) must be approved by an IRB.