There are various methods of study when it comes down to clinical research study. The double-blind study is an important type.
A clinical research study is an experimental study carried out using human subjects. The goal of the study is usually to generate data on safe and durable interventions.
In the double-blind study, neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results.
Our goal in this article is to help you properly understand the double-blind study.
Read along as we take you through the details.
What Is Double Blind Study? A Closer Look at Double-Blind Studies
In clinical research study, it is said to be double-blind if both the participants and researchers are not aware of the treatment allocation.
Let’s look more closely at a double-blind study. Doing this will give us a proper understanding of the question at hand.
The double-blind study means that the participants and those carrying out the research are unaware of the individual receiving the real treatment. For a particular clinical study, the researchers might decide to use a placebo. A placebo is a substance that will have no effect on whoever takes it.
In this study, the participants are not aware that they are taking a placebo. The placebo pill is given to participants who are randomly assigned to the control group.
The control group is a subset of participants who are not exposed to any levels of the independent variable. They serve as a baseline to determine if exposure to the independent variable has any significant effects.
Those randomly assigned to the experimental group are given the treatment in question. The data collected from both groups is then compared to determine if the treatment had some impact on the dependent variable.
All participants in the study will take a pill, but only some of them will receive the real drug under investigation. The rest of the subjects will receive an inactive placebo.
Double-blind trials are seen as the most reliable type of study because they involve neither the participant nor the doctor knowing who has received what treatment.
In simple terms, neither the participants nor the researchers are aware of who is taking the placebo or who is taking the real drug.
In scientific research, participants are often randomly assigned to one of two groups. In the treatment or experimental group, participants are given a treatment that the researchers think might have some type of interesting effect.
Participants in the control group, however, receive no special treatment, so they represent how people behave under normal circumstances. The participants must not know to which of those two groups they were assigned.
Origin Of Double-Blind Studies
The concept of double-blind studies originated in the mid-20th century. The need for such a study design arose from the understanding that bias could significantly affect the results of a study. The double-blind method was seen as a way to control for these biases and ensure more accurate and reliable results.
Over time, the double-blind study design has become a cornerstone of clinical research. It is now widely accepted as the most reliable method of testing the efficacy of new treatments and interventions.
Issues of Concern
Blinding covers any of the numerous participants of the clinical trial, e.g., researchers, subjects, technicians, and data analysts.
The major issue of concern is that blinding is not possible to achieve in all clinical trials. For example, the method of drug delivery may not be amenable to blinding. An excellent clinical protocol may help ensure that, within ethical and practical constraints, blinding is achieved as effectively as possible.
Why Should You Use A Double Blind Study?
There is a purpose and a reason for almost every procedure on earth, and the double-blind study is not left out.
The following are reasons why you should use a double-blind study:
1. Bias Is Minimized In The Double-Blind Study
A key purpose of the double-blind study is the minimization of bias. In the presence of bias, a study can be affected significantly or negatively.
The study effectively cuts this out by ensuring that both researchers and participants are unaware of what is to be carried out.
To give a simple example, if a participant knows they are receiving a placebo, can you guess what would happen?
Your guess might be right; they may report fewer improvements due to their belief that the treatment is not real.
Furthermore, if researchers know which group a participant is assigned to, they might act in a way that reveals the assignment or directly influences the results. They may unconsciously influence the participants or interpret the results in a way that supports their hypothesis.
Hence, the double-blind study minimizes both conscious and unconscious bias.
2. The Double-Blind Study Enhances Credibility
The credibility of clinical research is enhanced when a double-blind study is carried out.
Recall the very first advantage, which is bias minimization. By eliminating bias, these studies produce results that are more likely to be accurate and reliable.
When bias is eliminated, the trustworthiness of the research is increased. It also makes it more likely for the results of the research to be accepted by the scientific community and the public.
Furthermore, double-blind studies can also increase the likelihood of a study being published in a peer-reviewed journal. These journals often require rigorous methodology, and double-blind studies are seen as a strong indicator of high-quality research.
3. The Ethical Considerations Of Double-Blind Study
For clinical research or during the testing of the durability and effectiveness of a new drug, double-blind studies are often preferred.
These study play an important role in protecting the rights and well-being of participants.
4. The Generalizability Is Enhanced
When a double-blind study is carried out, the probability of the results reaching and covering a wider population is increased. It helps broaden the population of people that could fall within the purpose of the study.
5. In Double-Blind Study There Is Room For Result Duplication
The results of a double-blind study can be duplicated and that is why this procedure is considered one of the best practices. A double-blind study allows other researchers to follow up with the same processes, apply the test item, and compare the result with the control group.
The usefulness of this method is that if the results from these studies are close, it proves the validity of the test item that was administered.
What Are Some Shortfalls Of The Double-Blind Study?
1. The Cost Is High And The Study Is Complex Complex And Costly
One major shortfall is the high and expensive cost of carrying out a double-blind study. It is no child’s play, as it could be very complex.
Conducting this study may cost billions of dollars, thereby making the medicine expensive in the market.
2. It Cannot Be Applied For Every Research
Double-blind studies are not always practical or ethical for every research question or setting, especially in fields where blinding is difficult or impossible, such as behavioral or psychological research.
3. Ethical Concerns
In some cases, withholding a potentially beneficial treatment from participants (by giving them a placebo) can raise ethical concerns, particularly when the condition is serious and life-threatening.
4. Blinding Failures
Many theories have been raised, questioning the possibility that participants and researchers are actually unaware of the drugs, thereby unblinding the study. This, in turn, compromises the integrity of the results.
5. There Could Be A Negative Reaction
In some cases, some of the participants may react negatively to the treatment item. When this happens, the results from the test can be compared to see what changed.
Some participants may react negatively to the placebo, which may lead to some side effects that may make it seem like they were receiving the treatment item when they were not.
The Process Involved In Double-Blind Study
To be effective, it is generally recommended that double-blind trials include around 100–300 people. If treatments are highly effective, smaller numbers can be used, but if only 30 or so patients are enrolled, the study is unlikely to be beneficial.
The assignment of patients into treatments is typically done by computers, where the computer assigns each patient a code number and treatment group. The doctor and patients only know the code number to avoid bias, hence allowing the study to be double-blind.
Double-blind trials can come in different varieties. Double-blind, placebo-controlled studies involve no one knowing the treatment assignments to remove the chance of placebo effects.
In a double-blind comparative trial, a new treatment is often compared to the standard drug. This allows researchers to compare an established drug to a new one to establish which one is more advantageous.
However, unlike double-blind, placebo-controlled trials, they are not very good at statistically evaluating if a treatment is effective overall.
The main principle behind double-blind and randomized trials, as opposed to simple blind trials, is to avoid bias in the treatment or experimental set-up.
For example, if researchers are aware of the different treatment groups they are getting, they may avoid assigning more unwell patients to the treatment group. Therefore, any effect seen by the treatment may have been related to how unwell a patient was to start with rather than the efficacy of the drug.
Conclusion
A double-blind study is an important part of clinical research. Double-blind study is usually seen as the the most reliable type of study.
This is because they involve neither the participant nor the doctor knowing who has received what treatment. The aim of this is to minimize bias.
In this study, the risk of anyone influencing data or influencing the participants is minimized as a double-blind study prevents this.
How? By preventing both the researcher and the participants from obtaining knowledge of the study.
The Double-Blind Study provides an outstanding group of methods that help increase the credibility of the research. Even though the study is flawed and has some disadvantages, it is widely accepted as the gold standard in clinical research.
