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How to maintain the maximal level of blinding in randomisation for a placebo-controlled drug trial

Abstract:

We illustrate the approach of randomising treatments and compare it with the traditional approach of randomising patients, using a case study drawn from the authors’ experience in clinical trials. The setting is a double-blind parallel two-arm randomised controlled trial (RCT), but the method in this paper can be extended to single-blind, cross-over, or multi-arm RCTs. We propose the concept of two different levels of blinding: full blinding and partial blinding. We subsequently show how to ...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1016/j.conctc.2019.100356

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Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Sub department:
Centre for Statistics in Medicine
Oxford college:
Kellogg College
Role:
Author
ORCID:
0000-0001-5595-8468
More by this author
Institution:
University of Oxford
Division:
MPLS Division
Department:
Engineering
Sub department:
Institute of Biomedical Engineering
Role:
Author
Publisher:
Elsevier Publisher's website
Journal:
Contemporary Clinical Trials Communications Journal website
Volume:
14
Article number:
100356
Publication date:
2019-04-09
Acceptance date:
2019-04-05
DOI:
ISSN:
2451-8654
Source identifiers:
992884
Keywords:
Pubs id:
pubs:992884
UUID:
uuid:4230d82c-2bd4-45a8-90aa-ef042100adb6
Local pid:
pubs:992884
Deposit date:
2019-04-25

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