There are different types of clinical trials that call for participants. These trials are important for ensuring that medicine can advance, for improving scientific knowledge, and for giving patients access to better care. Something that you’ll often come across is the use of a placebo in clinical trials.
Placebos help researchers get a better idea of how well a substance (drug, treatment or intervention) really works. It also offers a group that data can be compared to. In this article, you’ll learn more about the purpose of placebos and why they are used.
- What is a placebo in clinical trials?
- What is the placebo effect?
- What is the main reason for using a placebo in an experiment?
- How are placebos used in clinical trials?
- Are placebos always used in clinical trials?
- Is it unethical to use a placebo in a clinical trial?
- How do I know if I’m taking a placebo?
- What next?
Use the links above to skip ahead to the questions you’re most interested in.
What is a placebo in clinical trials?
Placebos in clinical trials are a substance that doesn’t have a therapeutic effect. It’s quite the opposite of the drug that’s being studied, which is a substance that focuses on treating a specific condition or health problem.
They’re used in clinical trials to compare the impact of a placebo to that of the real drug that needs to be assessed.
Patients sometimes experience improvements in their condition even when using a placebo. This is mostly attributed to the psychological effect that’s present when the patient knows that they are taking a drug, but are not aware of whether it’s a therapeutic or placebo substance. There are many advantages of using placebo in clinical trials, which you’ll learn more about later on in this article.
What is the placebo effect?
The placebo effect is when participants in a clinical trial start to experience improvements in their condition while they’re in the placebo group. It’s not uncommon for this to happen.
The improvements that these participants experience is not due to the use of the placebo. Instead, neurobiological and psychological factors are considered to be the main elements in play when the placebo effect occurs. For example, 62% of the drug response in antidepressants is down to the placebo response.
What is the main reason for using a placebo in an experiment?
Placebos are used for different purposes in a clinical trial. However, one thing to keep in mind is the importance of placebo in clinical trials. They help researchers see how effective a new drug is compared to a substance that has no therapeutic value.
When clinical trials use a placebo, it also gives the study the opportunity to avoid biased opinions and reports. This is because most medical staff at the facility won’t know which patients are in the different groups that are being studied.
How are placebos used in clinical trials?
You may be wondering, how are placebos used in clinical trials? When clinical trials are initiated, they first determine the safety of a new substance that was created. They then need to consider the effectiveness of the drug, and later compare it to existing treatments.
This is why placebos are often not used in the early phases of a clinical trial. It’s more common to see placebos in later clinical trials phases such as Phase III and Phase IV.
At this point, the drug has already gone through various trials. Volunteers had a good response in terms of efficacy and safety while using the new drug.
Now, the researchers can turn to placebos to determine how it would compare to a treatment that has no therapeutic effects. Placebo use in clinical trials means that this particular control group will not receive a drug that has any physiological effects. Meanwhile, the experimental group receives the treatment and the results can be compared.
When placebos are implemented as part of the clinical trial, they are often also going to be used to see how the new drug works in comparison to what they call the placebo effect.
Are placebos always used in clinical trials?
Not every clinical trial will use placebos. This is because there are different kinds of these trials. Some of them will focus on determining how safe a specific drug is, for example. In this case, only the new treatment will be used in the clinical trial.
However, when the clinical trial must collect more evidence of how the new treatment works compared to cases where a non-therapeutic substance is used, placebos do play an important role in ensuring that the researchers can gather the data they need.
Is it unethical to use a placebo in a clinical trial?
While the topic remains controversial, it’s generally not considered unethical when placebos are used in a clinical trial. Something that you should keep in mind is that every volunteer who is eligible to be included in the study will go through an informed consent process.
During this process, you’ll be told everything that you need to know about the study. This includes whether there will be placebos and how participants will be grouped. These studies also offer patient empowerment, which means that you’re given a chance to withdraw from the clinical trial at any point should you feel the need to.
At FluCamp, we’ve had several people participate in clinical trials. Volunteers such as Jonathan and David give a clear overview of how informed consent helps them be more wary of what they are signing up for, and how our staff members implement ethical strategies when using placebos.
How do I know if I’m taking a placebo?
During informed consent, you’ll be made aware of the fact that there are placebos that will be used in the clinical trial. However, in most cases, you won’t know if you’re taking the actual drug or a placebo. This is important, as it helps to improve the quality and accuracy of the results that the researchers are able to gather during the study period.
There are two different methods that researchers use to determine who will take a placebo and which participants will receive the drug. In blinding assignments, the group won’t know what they are taking. In this type of trial, the data regarding who is in which group will also not be available to clinical staff members who provide assistance at the facility.
Randomised assignment uses a system that randomly assigns participants to one of the groups. In many cases, this type of study will also not reveal which participants are getting the drug or placebo. Doctors who are involved in the study may also be kept in the blind to ensure that there is no biased data reported during the clinical trial period.
FluCamp is a leading clinical research organisation dedicated to advancing medical knowledge in a safe and controlled manner, through innovative clinical trials, and ensuring that participants understand potential placebo use within our trials.
What next?
Placebos can be really helpful in getting more insight into a drug that a clinical trial studies. While it’s not used in every type of clinical trial, it’s important to understand the role it plays. Placebos can be used in a variety of trials, including some of the studies that FluCamp conducts. Reach out to learn more about FluCamp studies. You can also contact us if you’re interested in becoming a volunteer in a clinical trial.
