Dear Moacyr,
Hope all is well. This is a good question. The best way to answer this
question it is to give you an example. Let's say you want to randomize patients
to two different treatment options but one is a pill and the other comes as
injection. Obviously the patient and investigator will know what treatment the
person is taking by determining if they took an injection or a pill. So
what you do is give a sham pill (e.g. sugar) to all patients that are randomized
to take the active injection and vice versa. Therefore everyone gets an
injection and a pill. Of course the sham injection pill should have the same
physical characteristics and show the same effects (e.g. taste, smell, etc.) as
the active treatment option or else the active medication can still be
deciphered. Now the trial is a double-dummy trial.
Hope this helps.
Thank you for your time and consideration.
Please accept my regards.
Sincerely,
Ahmed
_______________________________________
Ahmed M.
Abou-Setta, MD, PhD
Independent researcher/ systematic reviewer
Consulting Senior Systematic
Reviewer,
Chalmers Research Group, CHEO Research Institute (CHEO
RI)
Children's Hospital of Eastern Ontario, University of
Ottawa
Member, Editorial Advisory Board, The Open Medical Devices Journal
Member, Geneva Foundation for Medical Education & Research
Member,
Menstrual Disorders & Subfertility Subgroup, Cochrane Collaboration
5, El-Ashwal Street, from Pyramids Road
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Giza, Egypt
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Sent: Monday, January 12, 2009 2:06 AM
Subject: double-dummy clinical trial
Do anyone help me with the meaning of "double-dummy clinical trial". Each one
of the groups takes a imitation of the active drug of the other group? Do you
have a exemple?
Thank you very much
--
Moacyr