When performing clinical trials you will often see the design of these trials will be randomized and blind. But what do these terms mean?
A randomized trial refers to how the control or the test medication or device is being distributed to the patients. They are distributed at random without pre selection of who receives which medication or device.
The term blind refers to an unawareness of which group receives which treatment. With a single blind study, the doctor and the principal investigator are aware of who receives which treatment, but the patient is unaware of whether they received the actual medication or a placebo.
In the case of a double blind study, neither the physician nor the patient is aware of which treatment was distributed; however, the scientists is aware of which group received which treatment.
In the case of a triple blind study neither the physician the principal investigator nor location are where of which grew perceived mistreatment that is not discovered until after raw data is analyzed. In the case of a triple blind study, neither the physician, the principal investigator, nor the location are aware of which group received mistreatment that is not discovered until after raw data is analyzed.
The purpose of blinding and randomization is to eliminate any potential bias and oversampling of a particular subject group, respectively. Theoretically, the double-blinded and triple-blinded studies are supposed to be the gold standard in achieving evidence-based results. I often wonder how big of a role does subject or researcher bias play in the study results. I seen numerous studies of indigenous medicines and non-traditional medical approaches produce where thousands of patients got better or recovered, yet the method gets discarded because a double-blinded study was not done. In such cases, I become frustrated with scientific method. If multitudes of patients are saying this approach helped me to get better, to me, a double-blinded study is not necessary to establish its effectiveness. If we can glean from a study, the reasons why the treatment worked with a dataset more than 10,000 subjects, then we can certainly make conclusions about its effectiveness and efficacy.
The triple blind study is the more accurate in terms of bias elimination. Also, as professor Simon said in the lecture, the good Doctor of Medicine or a good center reputation can affect on the clinical trial as psychological influence. Therefore, the randomization, multi-center selection, and placebo method all are used to make sure that no psychological effect on the clinical trial results.
Randomization and blinding are considered to be characters of best study design, but the "Gold Standard" Clinical trial are Randomized double blind placebo control. It eliminate the influence of immeasurable variables that may lead to biased and incorrect estimate of treatment effect.
It is important to blind and randomize during clinical trials. Like others have stated, randomization helps to ensure that the different groups are all tested with a diverse population. This helps to test a treatment or device through a wider range of patients. Blinding is another technique in which as many parties involved are kept in the dark about which treatment type is being administered to which group. This prevents any biases from forming. I investigated blinding a little bit more and found an article that explained blinding very well in terms of why it is useful, when it should be used, and the different types of blinding possible. [1] I have provided the link for this below. Apart from this, a few students mentioned the “gold standard” [2] and I found the paper from which I believe they were referring too. This paper also provides a great description of all the steps that could be taken during clinical trials to reduce bias and reduce any other potential interferences with the results. I have included this link below as well.
Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of different medical treatments. Both randomization and blinding are important tools in determining the effectiveness of a clinical intervention and ensures the validity of a clinical trial. However randomization cannot overcome the poor experimental design, it only provides a solid basis for statistical analysis. They can help reduce statistical errors.
Randomization is a method of assigning patients to research treatment groups that reduces bias and allows for an unbiased assessment of the effects of various medical therapies. Randomization and blinding are key techniques for assessing the efficacy of a clinical intervention and ensuring the trial's validity. Randomization, on the other hand, cannot compensate for bad experimental design; it can only offer a strong foundation for statistical analysis. They can aid in the reduction of statistical mistakes.
Blinded studies are those in which either the patient, doctor, or scientist is not aware which group is getting the actual drug vs. the placebo. There are single blind (patient is unaware), double blind (patient and doctor are unaware), and triple blind (patient, doctor, and scientist are unaware).
Randomized studies are those in which patients are allotted to treatment groups randomly, in no particular order. The randomization is controlled by different mathematical/statistical formulas and schemes.
By combining these two aspects the results are most likely to be unbiased and accurate to real world application. In particular, triple blind studies will ensure that everyone involved in the study and data collection process is unaware who has the actual drug and thus will allow the results to be collected in an unbiased manner. The randomization in group formation will most closely resemble the diversity of patients using the drug in the the real world application.
Randomization, in which people are assigned to groups by chance alone, helps prevent bias. Bias happens when a trial's results are affected by human choices or other factors not related to the treatment being tested. It differs from a blinded trial where you do not know which group you are in and which intervention you are receiving until the trial is over. This trial helps prevent bias. For example, if patient or doctors knew the patient's treatment group, it might affect the way they report different health changes. However, not all treatment trials can be blinded. The unusual side effects of a new treatment or the way in which it is given may make it clear who is getting it and who is not.
