What is a clinical trial?
A clinical trial helps researchers to understand if a new drug, a new combination of drugs, surgical procedure, medical device, diagnostic method, prevention method or other treatment is effective for a specific health condition, and is safe to use.
Why are clinical trials important?
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.
What does it mean to volunteer in a clinical trial?
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?
What is expected of me when I participate in a clinical trial?
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.
Where do I find clinical trials?
You can find clinical trials directly via www.clinicaltrials.gov, but you can also sign up with Citruslabs and we automatically match you with a clinical trial in your area that fits your needs.
What are the different steps involved to participate in a clinical trial? What are the different types of clinical trials?
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.
What are the benefits of participating in a clinical trial? What are the risks of participating in a clinical 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.
What is a protocol?
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.
What is a placebo?
Usually, only blinded trials use a placebo, which is an inactive drug or treatment, sometimes also referred to as a “sugar pill”. If you take the placebo, you are in the control group and the goal behind that is to see how the researched drug or treatment compares to the placebo.
What is informed consent?
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.
What happens during a phone and on-site screening?
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.
How long does a clinical trial last?
How long a clinical trial lasts depends on the protocol. It usually lasts from six months to 24 months, but can also last shorter or longer. We encourage you to ask this question to the research staff.
Do I get paid to participate in a clinical trial?
Usually, participants in a clinical trial get reimbursed for their travel expenses and time.
Do I have to pay something to participate in a clinical trial?
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.
How is the safety of a clinical trial participant protected?
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.
Can I still see my primary care provider?
Clinical trials should be seen as short-term care. Hence, you will in most cases continue to see your primary care provider (pcp), also during your participation in a clinical trial. Your pcp may have even referred you to a clinical trial.
Can I change my mind when I participate in a clinical trial and drop out?
Participating in a clinical trial is 100% your own choice and you should not be forced to participate in a clinical trial. You can also drop out during a clinical trial at any time and should not be forced to continue with the trial if you don’t want to.
