Non-enrolment of ovarian cancer patients in clinical trials: reasons and background
Annals of OncologyPublished 9 August 2005Open access
Philipp Harter, Andreas du Bois, Carmen Schade‐Brittinger, Alexander Burges, K. Wollschlaeger, M. Gropp
Citations43
SJR quartileQ1
SJR score19.07
SNIP10.48
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TL;DR
The results suggest that at least some inclusion criteria for clinical trials should be modified to increase study participation without compromising safety.
Abstract
Study patients differ substantially from non-study patients, thus hampering generalisation of study results. Our results suggest that at least some inclusion criteria for clinical trials should be modified to increase study participation without compromising safety.
Keywords
MathematicsMedicineBiochemistry, Genetics and Molecular Biology
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