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Types of Blinding in Clinical research

 TYPES OF BLINDING IN CLINICAL RESEARCH

BLINDING: 

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Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatment arms participants have been assigned to, i.e. which treatment was received.


Blinding is an important aspect of any trial. How a trial was blinded should be accurately recorded in order to allow readers to interpret the results of a study. If blinding is ever broken during a trial on individual participants, it needs to be justified and explained

TYPES OF BLINDIND:

         Blinding                                                          Description

Unblinded or open label                            All are aware of the treatment(s) 

Single blind or single-masked                   The participants are blinded but no one else is masked

Double blind or double-masked                The participants and clinicians / data collectors are blinded 

Triple blind                                                The participants, clinicians / data collectors and outcome                                                                                 adjudicators / data analysts are blinded 



OPEN BLINDING:
An open-label trial is one in which no blinding is used and all parties are aware of the allocation of participants to treatment groups.

Open-label trials may be used:

  • For surgical procedures*.
  • When changes in lifestyle are required.
  • When endpoints are objective and cannot be interpreted in different ways.
  • For studies in life-threatening situations.
  • In post-marketing surveillance.
  • When ethical considerations do not permit blinding.
  • When no control group can be used.


SINGLE BLINDING:
A trial in which one party, the investigator or, usually, the participants, is unaware of what medicine the participant is receiving. Also called single-masked studies they provide some control when double blinding is impossible or not appropriate.
Single-blind trials are used where the experimenters either must know the full facts (for example, when comparing sham to real surgery) and so the experimenters cannot themselves be blind, or where the experimenters will not introduce further bias and so need not be blind. However, there is a risk that subjects are influenced by interaction with the researchers – known as the experimenter's bias.

DOUBLE BLINDING:

A clinical trial design in which neither the participants nor investigators know which participants are receiving the experimental medicine and which are receiving a placebo (or comparator therapy). Double-blind trials are thought to produce objective results, since the expectations of the investigator and the participant do not affect the outcome. Also called double-masked trial.

  • Considered best-controlled trial design.
  • Decreased chance of preconceived notions or physical cues (e.g. the placebo effect, observer bias, experimenter's bias) to distort the results.
  • The key that identifies the participants and which group they belonged to is kept by a third party, and is not revealed to the researchers until the study is over.
  • Should be used whenever possible.
In trials in studies comparing two active compounds (test medicine and comparator) and when the two treatments cannot be made identical, double dummy is a technique for retaining the blind. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Participants then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active).

For example, if we want to compare two medicines, one presented as green tablets and one as pink capsules, we could also supply green placebo tablets and pink placebo capsules so that both groups of patients would take one green tablet and one pink capsule.

TRIPLE BLINDING:

A triple blind trial means that participants, clinicians, data collectors, outcome adjudicators and data analysts do not have access to details of group assignment. This ensures that bias for or against the tested treatment is very unlikely to occur.

  • Medicine may still be labelled as A or B during analysis.
  • Analyst is blinded to which treatment is which.
  • Helps to avoid bias in the analyzed results.


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