European Patients’ Academy

on Therapeutic Innovation

Blinding in clinical trials

Blinding of the trial
European Patients’ Academy
on Therapeutic Innovation

▪ 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 in order to avoid bias.
▪ 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 broken during a trial on individual patients, it
needs to be statistically and/or ethically explained at the
end.

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Why do we blind?
European Patients’ Academy
on Therapeutic Innovation

▪ Blinding is used to prevent conscious or unconscious

bias in the design of a clinical trial and how it is carried
out.
▪ This is important because bias can affect recruitment
and allocation, care, attitudes, assessments, etc.
▪ It is used to ensure the objectivity of trial results

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What are the potential sources of
bias in a trial? European Patients’ Academy
on Therapeutic Innovation

 Sources of bias include:

 Patient being treated
 Clinical staff administering treatment
 Doctor assessing treatment
 Team interpreting trial results

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Who can be blinded in clinical trials?
European Patients’ Academy
on Therapeutic Innovation

▪ Participants in a trial
▪ Clinicians and data collectors
▪ Outcome adjudicators and data analysts

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Types of blinding
European Patients’ Academy
on Therapeutic Innovation

Type Description
Unblinded or All are aware of the treatment the
open label participant receives
Single blind or Only the participant is unaware of the
single-masked treatment they receive
Double blind or The participant and the clinicians / data
double-masked collectors are unaware of the treatment
the participant receives
Triple blind Participant, clinicians / data collectors and
outcome adjudicators / data analysts are
all unaware of the treatment the
participant receives.
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Unblinded trial
European Patients’ Academy
on Therapeutic Innovation

▪ A trial in which no blinding is used and all parties are

aware of the treatment groups. Also called open label.
 Should be used:
 For surgical procedures*
 When changes in lifestyle are required
 When endpoints are objective and cannot be interpreted in
different ways
 For case studies with life-threatening situations
 In post-marketing surveillance
 When ethical considerations do not permit blinding
 When no control group can be used
*It should be noted that surgical procedures can be blinded but are extremely difficult to blind. This is
very hard especially if participants can be compared. 7
Single-blind trial
European Patients’ Academy
on Therapeutic Innovation

 A trial in which one party, either the investigator or

participant, is unaware of which treatment the participant
is taking. Also called single-masked trial.
 Provides some control when double blinding is
impossible
 Used when the experimental medicine and control
cannot be manufactured identically

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Double-blind trial
European Patients’ Academy
on Therapeutic Innovation

 A clinical trial design in which neither the participants nor

the study staff know which participants are receiving the
experimental medicine, and which are receiving a
placebo (or another therapy).
 Double-blind trials are thought to produce objective
results, since the expectations of the doctor and the
participant do not affect the outcome. Also called double-
masked trial.
 Best-controlled trial design
 Decreased chance of observational bias
 Should be used whenever possible
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Triple blind
European Patients’ Academy
on Therapeutic Innovation

 A triple blind trial means that patients, clinicians, data

collectors, outcome adjudicators and data analysts are
denied 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
 The analyst is blinded as to which treatment is which
 Helps to avoid bias in the analysis of results.

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Unblinding the trial
European Patients’ Academy
on Therapeutic Innovation

▪ Unblinding is the disclosure of the treatment to a

participant or study team. It protects the participants in
case of medical or safety reasons.
▪ In a crossover design, the participant may only be
unblinded for the most recent dose.
▪ The protocol for unblinding should be described upfront,
and must include information about when and by whom
is to be done.

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References
European Patients’ Academy
on Therapeutic Innovation

▪ Karanicolas, P., Farrokhyar, F., & Bhandari, M. (2010).

Blinding: Who, what, when, why, how? Canadian Journal
of Surgery, 53(5), 345–348. Retrieved 21 August, 2015,
from
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2947122/
▪ Schulz, K.F., Grimes, D.A. (2002) Blinding in randomised
trials: hiding who got what. Lancet, 359, 696-700.
Retrieved 21 August, 2015,
fromhttp://apps.who.int/rhl/LANCET_696-700.pdf

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