What is a blind and double blind drug trial

Placebos can be used for blinding in statistics. A placebo or dummy pill is an inert inactive substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient. For example, placebo pills or liquids may contain starch, sugar, or saline. Researchers use placebos during studies to help them understand what effect a new drug or some other treatment might have on a particular condition. For instance, some people in a study might be given a new drug to lower cholesterol.

Others would get a placebo. Most doctors will tell you they have used placebos. Prescribing placebos is not illegal, but can be unethical if recipient has no idea that he or she is getting a sugar pill. The drug Adderall is a combination of the stimulants amphetamine and dextroamphetamine, and is used to treat attention deficit hyperactivity disorder ADHD.

Adderall is a stimulant that boosts your levels of serotonin, norepinephrine, and dopamine. These are neurotransmitters in your brain that calm and relax you so you can focus better.

New research has explored the potential side effects of the stimulant drug Ritalin on those without ADHD showed changes in brain chemistry associated with risk-taking behavior, sleep disruption and other undesirable effects. Login: Training Managers Login: Students. Student Login Friday, January 14, Training Certifications. More Information. That process would violate the principles of informed consent.

The double-blind structure avoids this issue by providing complete information to all participants without letting on who receives the actual product getting studied. It reduces the issue of experimenter bias. Using double-blind procedures can minimize the potential effects of research bias when collecting data. This issue often occurs when experimenters knowingly or unknowingly influence the results during information gathering or product administration during the project.

There can also be subjective feelings that drive specific decisions that would occur if less information was present in the study. By limiting the potential influences that could impact the collected data, the final results produced by the research or experiment has more validity.

The results of a double-blind project can get duplicated. One of the reasons why a double-blind study is considered a best practice is because the results offer the potential for duplication. Other researchers can follow the same protocols for administering placebos and the item being examined against a control group. If the results are similar, then it adds even more validity to the ability of a product or service to provide benefits. Double-blind assignment factors are randomized.

No one knows who is going to be part of what group at the beginning of a double-blind study. When looking at an intervention-based process, the fact that random assignment occurs for willing participants works to reduce the influence of confounding variables in the material.

High levels of control are part of the research process. The context of a double-blind research study allows administrators to manipulate variables so that the setting allows for direct observation. Control factors that could influence the environment can get added or removed to assist with the limitation of outside factors that would potentially change the data. This process allows for an accurate analysis of the collected data to ensure the authenticity of the results gets verified.

The double-blind study might be used primarily by the pharmaceutical industry because it can look directly at the impact of medication, but any field can use the processes to determine the validity of an idea. Agriculture, biology, chemistry, engineering, and social sciences all use these structures as a way to provide validation for a theory or idea. When a patient receives a pill after going to the doctor, they are told that the product is actual medicine intended to provide specific results.

Blinding covers any of the numerous participants of the clinical trial, e. Single-, double-, and triple-blinding are commonly used blinding strategies in clinical research. A single-blind study masks the subjects from knowing which study treatment, if any, they are receiving. A double-blind study blinds both the subjects as well as the researchers to the treatment allocation.

Triple-blinding involves withholding this information from the patients, researchers, as well as data analysts. Randomized, double-blind placebo-controlled trials involve the random placement of participants into two groups; an experimental group that receives the investigational treatment and a control group that acquires a placebo. Neither the researchers nor the study subjects know who is getting the experimental treatment and who is getting a placebo. This type of clinical study ranks as the gold standard for the validation of treatment interventions.

Unfortunately, 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 the ethical and practical constraints, blinding is achieved as effectively as possible.

Bias refers to a deviation from the truth in the collection, analysis, interpretation, or publication of data, leading to false conclusions. Poor blinding of a clinical research study may lead to bias that may result in inflated effect size and increase the risk of type I error. Even a small error in blinding may lead to a statistically significant result without any real difference between the study groups.

Keeping both the researchers and the subjects blinded to treatment allows a double-blinded study to prevent the researchers from treating the study groups differently. The double-blinded study minimizes the risk of various types of biases, such as observer bias or confirmation bias, which may influence the results of the investigation. Unblinding may occur during any portion of the blinded clinical trial.