What is a double-blind study

In experimental research, subjects are randomly assigned to either a treatment or control group. A double-blind study withholds each subject’s group assignment from both the participant and the researcher performing the experiment.

If participants know which group they are assigned to, there is a risk that they might change their behavior in a way that would influence the results. 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.

Double blinding guards against these risks, ensuring that any difference between the groups can be attributed to the treatment.

Different types of blinding

Blinding means withholding which group each participant has been assigned to. Studies may use single-, double- or triple-blinding.

Single-blinding occurs in many different kinds of studies, but double- and triple-blinding are mainly used in medical research.

Single blinding

If participants know whether they were assigned to the treatment or control group, they might modify their behavior as a result, potentially changing their eventual outcome.

In a single-blind experiment, participants do not know which group they have been placed in until after the experiment has finished.

What is a double-blind study

Example: Single-blind vaccine studyYou have developed a new flu vaccine. In order to test the effectiveness of your new treatment, you run an experiment, giving half of your participants the flu vaccine and the other half a fake vaccine that will have no effect.

If participants in the control group realize they have received a fake vaccine and are not protected against the flu, they might modify their behavior in ways that lower their chances of becoming sick – frequently washing their hands, avoiding crowded areas, etc. This behavior could narrow the gap in sickness rates between the control group and the treatment group, thus making the vaccine seem less effective than it really is.

To prevent such an outcome, in a single-blind study, you hide from the participants which vaccine – real or fake – each of them received.

Double-blinding

When the researchers administering the experimental treatment are aware of each participant’s group assignment, they may inadvertently treat those in the control group differently from those in the treatment group. This could reveal to participants their group assignment, or even directly influence the outcome itself.

In double-blind experiments, the group assignment is hidden from both the participant and the person administering the experiment.

What is a double-blind study

Example: Double-blind vaccine studyIn the flu vaccine study that you are running, you have recruited several experimenters to administer your vaccine and measure the outcomes of your participants.

If these experimenters knew which vaccines were real and which were fake, they might accidentally reveal this information to the participants, thus influencing their behavior and indirectly the results.

They could even directly influence the results. For instance, if experimenters expect the vaccine to result in lower levels of flu symptoms, they might accidentally measure symptoms incorrectly, thus making the vaccine appear more effective than it really is.

To avoid this, you hide group assignments from both the participants and the experimenters giving the vaccines – a double-blind study.

Triple-blinding

Although rarely implemented, triple-blind studies occur when group assignment is hidden not only from participants and administrators, but also from those tasked with analyzing the data after the experiment has concluded.

Researchers may expect a certain outcome and analyze the data in different ways until they arrive at the outcome they expected, even if it is merely a result of chance.

What is a double-blind study

Example: Triple-blind vaccine studyIn your vaccine study, you have also recruited assistants to analyze the data you gathered on flu infection rates. You decide to hide the group assignments from the participants, the people administering the experiment, and the people analyzing the data – a triple-blind study.

To achieve triple blinding, you assign each participant to group 1 or group 2, but do not inform the data analysts which number represents which group.

Importance of blinding

Blinding helps ensure a study’s internal validity, or the extent to which you can be confident any link you find in your study is a true cause-and-effect relationship.

Since non-blinded studies can result in participants modifying their behavior or researchers finding effects that do not really exist, blinding is an important tool to avoid bias in all types of scientific research.

Risk of unblinding

Unblinding occurs when researchers have blinded participants or experimenters, but they become aware of who received which treatment before the experiment has ended.

This may result in the same outcomes as would have occurred without any blinding.

Example of unblindingYou are studying the impact of a new school instruction program aimed at improving students’ reading comprehension skills.

You randomly assign some students to the new program (the treatment group), while others are instructed with a standard program (the control group). You use single blinding: you do not inform students whether they are receiving the new instruction program or the standard one.

If students become aware of which program they have been assigned to – for example, by talking to previous students about the content of the program – they may change their behavior. Students in the control group might work harder on their reading skills to make up for not receiving the new program, or conversely to put in less effort instead since they might believe the other students will do better than them anyway.

Thus, the results of your study could be invalid unless you prevent any unblinding.

Inability to blind

Double or triple blinding is often not possible. While medical experiments can usually use a placebo or fake treatment for blinding, in other types of research, the treatment sometimes cannot be disguised from either the participant or the experimenter. For example, many treatments that physical therapists perform cannot be faked.

In such cases, you must rely on other methods to reduce bias.

  • Running a single rather than double- or triple-blind study. Sometimes, although you might not be able to hide what each subject receives, you can still prevent them from knowing whether they are in the treatment or control group. Single blinding is particularly useful in non-medical studies where you cannot use a placebo in the control group.
  • Relying on objective measures that participants and experimenters have less control over rather than subjective ones, like measuring fever rather than self-reported pain. This should reduce the possibility that participants or experimenters could influence the results.
  • Pre-registering data analysis techniques. This will prevent researchers from trying different measures of analysis until they arrive at the answer they’re expecting.

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What is a double-blind study
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This page tells you about randomised clinical trials. It has information about

What are randomised trials?
Why trials are randomised
The placebo effect
Blind trials
Double blind trials
 

What are randomised trials?

The video below shows how a randomised trial works. It is about 2 minutes long.

Read the full video transcript.

Randomised trials have at least 2 different treatment groups. The people taking part are put into one of the groups at random. This process is called 'randomisation' and is usually done by a computer. Most phase 3 trials and some phase 2 trials are randomised.

Often there is one group who have the standard treatment they would have if they weren’t in the trial. They are the control group.  People in the other group (or groups) have a new treatment or procedure that is being tested. A randomised trial that has a control group is called a randomised controlled trial (RCT).

Sometimes there is no standard treatment available for the control group. This could be because people have already had all the treatments currently available. In this situation, the people in the control group would have a dummy treatment. This is called a placebo

What is a double-blind study
.

Why trials are randomised

Researchers run randomised trials because they need to be sure that the results are correct. And that there is no bias

What is a double-blind study
that could distort the results. Of course, researchers are unlikely to be deliberately biased. But it is possible to be biased without realising it.

For example, doctors may avoid putting patients who are more unwell into a particular trial group without really meaning to. The people in this group then may not do as well as people in another group. This is because they were more unwell to begin with. The results would look as if the one treatment works better than the other, but really it doesn't.

The research team put information about the people taking part into the computer program. This might include the following:

  • your age
  • gender 
  • the size of your cancer and how far it has spread (stage)

This makes sure that the groups are as similar as possible. Then the researchers know that if one group does better than the other, it’s because of the different treatment. And not because of general differences in the people taking part.

What is a double-blind study

 

What is a placebo?

A placebo is a dummy treatment. 

Some trials compare a new treatment with a placebo. It looks exactly like the actual treatment. It's the same shape or colour of pill, or size of injection. 

Comparing a group of people taking a new treatment with a group taking a placebo can show if the new treatment is really working. A drug that actually works will work better than a dummy drug.

Researchers only use a placebo if there is no standard treatment available. The patients in the control group wouldn't have any treatment if they weren't in the trial. So they are not missing out on treatment they would otherwise have had.

It isn't ethical to give a placebo to a group of people who really need treatment for cancer. The research ethics committee would not give permission for a trial designed in that way. We have information about how trials are approved.

Blind trials

A blind trial is a trial where the people taking part don't know which treatment they are getting. They could be one of the following:

  • the new treatment
  • the standard treatment
  • a placebo

This depends on the design of the trial. All patients have identical injections or tablets, so they can't tell which treatment they are having.

Double blind trials

A double blind trial is a trial where neither the researchers nor the patients know what they are getting. The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups. Your treatment arrives with your code number on it. Neither you nor your doctor knows whether it is the new treatment or not.

The list of patients and their code numbers are kept secret until the end of the trial. In an emergency, the researchers could find out which trial group a patient was in. This is to check that the emergency wasn’t caused by the trial drug. But generally no one knows which treatment you had until the trial has finished.

We have information about

What trials are

Phases of clinical trials

How to find a trial