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Multiple-blind: Towards a new blinding protocol for future generations of clinical trials
Jafar Kolahi1, Mohamadreza Abrishami
1Dental Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. jafar.kolahi@gmail.com
Abstract:
In this hypothesis we try to suggest a new blinding protocol acting as a gold standard for design and conduction of unbiased clinical trials. All of the following five categories of key trial persons should be blinded to treatment allocation: (a) participants, (b) healthcare providers, (c) data collectors, (d) outcome assessors and (e) data analysts. Furthermore, personnel writing the manuscript should be blinded through submission two drafts of a manuscript, with draft 1 written assuming that group A is the treatment group and draft 2 assuming that group B is the treatment group. Also, double-blind peer review procedure (in which the reviewers' and authors' names and affiliations are not disclosed to one another) should be carried out. Test of the success of blinding should be used. Participants, healthcare providers and data collectors, should be tested for the success of blinding in early stage of the trial and at the end of the trial. For outcome assessors, data analysts, manuscript writers and peer reviewers one test session in the end of their work is enough.
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