Erschienen in:
16.03.2018 | Concise Research Reports
What Constitutes an Independent Statistical Analysis?
verfasst von:
Ann Abraham, BS, Rosa Ahn, BA, Alexandra Woodbridge, BS, BA, Erin Madden, MPH, Salomeh Keyhani, MD, MPH, Deborah Korenstein, MD
Erschienen in:
Journal of General Internal Medicine
|
Ausgabe 6/2018
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Excerpt
Potential bias in clinical trials related to relationships with the pharmaceutical industry is a longstanding concern.
1 Between 2005 and 2013, JAMA journals required industry-sponsored studies to conduct independent statistical analysis (ISA), defined as data analysis by an “independent statistician at an academic institution” using the raw data set.
2 While no journals currently require ISA, the term may be used to denote impartiality and robustness in data analysis.
2, 3 However, its meaning, frequency of use, and association with study characteristics are not clear. Our study’s purpose was to investigate the prevalence and characteristics of ISA in published RCTs focused on drug efficacy and their adherence to JAMA’s definition. …
