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Failure to report protocol violations in clinical trials: a threat to internal validity?

Overview of attention for article published in Trials, September 2011
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Title
Failure to report protocol violations in clinical trials: a threat to internal validity?
Published in
Trials, September 2011
DOI 10.1186/1745-6215-12-214
Pubmed ID
Authors

Elizabeth A Sweetman, Gordon S Doig

Abstract

Excessive protocol violations (PV), which can be defined as preventable mistakes in study conduct, may result in patient harm and introduce errors into a clinical trial's results leading to flawed trial conclusions.The purpose of this project was to gain a better understanding of reported PVs, to describe current practice with regards to the use of methods for the reduction of PVs and to investigate relationships between clinical trial characteristics and PVs.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 55 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 2 4%
India 1 2%
Unknown 52 95%

Demographic breakdown

Readers by professional status Count As %
Student > Master 12 22%
Student > Ph. D. Student 7 13%
Researcher 6 11%
Student > Postgraduate 6 11%
Student > Bachelor 6 11%
Other 14 25%
Unknown 4 7%
Readers by discipline Count As %
Medicine and Dentistry 22 40%
Nursing and Health Professions 4 7%
Agricultural and Biological Sciences 3 5%
Psychology 3 5%
Business, Management and Accounting 2 4%
Other 14 25%
Unknown 7 13%