Don't Get Stuck When Packaging and
Labeling Your Double Blind Clinical Studies
ISPE
Midwest Clinical Supplies
Group Meeting
12-January-2006
Dan Elman
Senior Manager
Clinical Supplies Packaging
1
OBJECTIVE
Discuss the concept of
Blinding
Explore some methods for
blinding
2
Packaging & Labeling
Double Blind Studies
What is “Blinding” ?
Why is it necessary ?
What are the types of
“Blinding” ?
3
What is “Blinding” ?
Blinding (sometimes called
masking) is a process utilised
in manufacturing and /or
packaging to attempt to
eliminate bias
4
Why Blind CT Materials ?
Human behaviour is influenced
by what we know or believe
Our knowledge, even if only
perceived, may influence a
clinical trial
5
Why Blind CT Materials ?
Therefore, the purpose of a
blinded trial is to ensure the
investigator, sponsor and
participant expectations do
not affect the results
6
Types of Blinded Trials
Single Blind
Only the investigator knows
which treatment the patient has
been assigned to
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Types of Blinded Trials
Double Blind
Both the investigator and
patient are unaware of which
treatment the patient has been
assigned to
8
Types of Blinded Trials
Triple Blind
Sometimes used to indicate that
a study statistician or the
sponsor is also blinded to the
treatment assignment of each
patient
9
Types of Blinded Trials
Third-Party Blind
A resource not invested in the
outcome of the trial is utilised to
prepare and / or administer the
treatment
1
Types of Blinded Trials
Double Dummy Blind
A method of blinding utilised
when the investigational and
comparator (control) product
cannot be manufactured to
match
1
Goals of a Blinded Product
Duplicating or approximating
the shape, size, color, taste
and weight of the drug
product or device
1
Goals of a Blinded Product
Matching packaging
instructions, packaging
components and clinical
labeling
1
Methods of Blinding
Solid Dosage Forms
Over-encapsulation
Overcoat
De-ink
Manufacture
1
Methods of Blinding
Inhalation Devices
MDI Blinding Devices
1
Methods of Blinding
Injectables / Vials / Ampoules
Infusion Bags
Over-label / De-label
Over-ink or dip
IV Bag Covers
1
Methods of Blinding
Semisolids / Tubes
Over-label
“Sheathing Tube”
1
Summary
Attributes of a well-controlled
study (21CFR314.126) include
comparison with a control (usually
in the form of a placebo, active
treatment or both) and adequate
measures to minimise bias
1
Summary
Bias can be minimised through the
process of blinding during
manufacturing and / or packaging
of clinical trial materials
1
Summary
Not every trial will be a candidate
for conventional blinding methods
and the use of Third Party Blinding
resources may be required
2
Summary
Thank you
2
References
Day, Simon J., “Blinding in Clinical Trials and
other studies,” British Medical Journal,
August 19, 2000
DeVito, Kristen, “Blinded by Science: Functional
and Unique Approaches to Blinding Clinical Trial
Material,” ISPE Webinar presented May 19, 2004
21 CFR 314.126
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New in 2005
Dedicated clinical packaging facility with 70,000 sq. ft. of new space colocated on Quintiles campus with pre-formulation, formulation,
analytical and manufacturing capabilities
Over 14,000 sq. ft. of flexible secondary packaging space which can be
easily configured to meet any need from large production lines to small
cubicles
Storage capacity for over 2,500 temperature and humidity controlled
and monitored pallets
Over 21,000 cubic feet of refrigerated storage
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