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A (small) one-sided P-value allows to conclude that one sponsoring type provides significant larger (or smaller) numbers of, for example, positive outcomes.
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We analyzed the ClinicalTrials.gov database contents as of June 2011, comparing interventions, medical conditions, and trial characteristics by sponsor type.
In addition, HKS principal investigators will be required to confirm that their HKS annual report is updated as applicable prior to the submission of new sponsor proposals, regardless of sponsor type (U.S. government, private foundation, etc). Additional disclosure requirements may be imposed on recipients of PHS grants under federal rules.
We tested for interaction between sponsor type and REC.
For product information and supporting documentation, the interaction between sponsor type and REC was p < .05.05
We controlled for the REC that reviewed the protocol by including both sponsor type and REC as predictors in the model, and tested for interaction between sponsor type and REC.
The shortcomings of protocols that are identified during REC review have not been compared by sponsor type though.
Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type.
However, to our knowledge, this is the first study in which shortcomings of protocols of drug trials as identified by RECs have been compared by sponsor type.
The total time between protocol submission and REC approval was compared by sponsor type and REC using a two-way ANOVA.
Associations between sponsor type and the number of trials that received comments were estimated with relative risks (RRs) and 95% confidence intervals (CIs).
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