2001
DOI: 10.1136/bmj.322.7286.603
|View full text |Cite
|
Sign up to set email alerts
|

Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility Commentary: Early discontinuation violates Helsinki principles

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
1
1
1

Citation Types

0
68
1
3

Year Published

2003
2003
2020
2020

Publication Types

Select...
9

Relationship

0
9

Authors

Journals

citations
Cited by 97 publications
(72 citation statements)
references
References 11 publications
0
68
1
3
Order By: Relevance
“…It has been suggested that trials may be stopped prematurely or a sponsoring company may attempt to obstruct publication of the results if the findings of the study are negative. [31][32][33][34] Although these occurances have not been directly investigated in the surgical literature, 2 publications in our review demonstrated that studies involving researchers with consultant/ employee status, royalties or stock options were associated with a higher likelihood of a positive outcome than those involving researchers who received only research support. 16,18 This implies a more sinister possibility that some investigators may be swayed by secondary interests and, in doing so, disregard the primary interest of study validity.…”
Section: Researchmentioning
confidence: 93%
“…It has been suggested that trials may be stopped prematurely or a sponsoring company may attempt to obstruct publication of the results if the findings of the study are negative. [31][32][33][34] Although these occurances have not been directly investigated in the surgical literature, 2 publications in our review demonstrated that studies involving researchers with consultant/ employee status, royalties or stock options were associated with a higher likelihood of a positive outcome than those involving researchers who received only research support. 16,18 This implies a more sinister possibility that some investigators may be swayed by secondary interests and, in doing so, disregard the primary interest of study validity.…”
Section: Researchmentioning
confidence: 93%
“…Reviewers' preferences matter as well; a randomized, well-controlled experimental study of peer review found that reviewers have strong preferences for positive findings over no-difference studies [2]. Finally, numerous statistical issues tend to drive results in a positive direction, including significance hunting, data dredging, posthoc hypothesis testing [8], premature halting of no-difference trials for inappropriate reasons [5], influence from the funding sources on the comparator groups chosen as study controls [4], and even on whether the study's findings can be released [1]. Journals, as arbiters of what is published, have an obligation to be mindful of the downward pressure against nodifference results.…”
Section: Numerous Incentives Alreadymentioning
confidence: 99%
“…Il est intéressant d'observer que des failles du système des promotions industrielles, beaucoup plus lourd et uniforme que celui des promotions institutionnelles, sont apparues. Elles ont été matérialisées par une analyse critique des recommandations de l'ICH (International conference on harmonisation) [1], par des arrêts prématurés des études pour des raisons commerciales [2,3] et des publications probablement incomplètes [4,5]. Simultanément, la protection des personnes se prêtant à des recherches biomédicales dans des promotions institutionnelles a été malheureusement mise en défaut par deux décès inacceptables [6,7].…”
Section: Forum Hypothèses / Débats M/s N° 10 Vol 22 Octobre 2006unclassified