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We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials.
It is desirable to increase the awareness of interventional cardiology trialists regarding checklists and guidelines for reporting trial quality such as the CONSORT Statements.
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41, 46 However, this creates dilemmas for clinicians and trialists, especially regarding patients with a poor survival prognosis or those for whom alternative experimental drugs may exist.
Despite the frequency of clustering in randomised trials, recent articles have highlighted the lack of awareness many trialists have regarding the issues clustering presents for the analysis [ 4- 6]; for example, Lee and Thompson found only 4/38 trials (11%) adjusted for clustering (and 3 of the 4 trials that did adjust for clustering did not account for all sources of clustering).
Our work provides richer information on trialists' decision making regarding selective outcome reporting than previous work has been able to capture.
This review is based on discussions between scientists, clinical trialists, and regulatory representatives regarding methods for improving international HHF trials that took place at the United States Food and Drug Administration on January 12th , 2012
Regarding the reanalysis of such open clinical trials data, we did not have to contact the original trialists for this study; questions regarding the RAVE study design were addressed by review of the primary publications from the RAVE trial.
Informants noted that many trialists continued to seek advice from such groups during the trial regarding specific issues.
More serious concerns regarding long-term efficacy emerged from the Early Breast Trialists overview [ 2], which confirmed excess cardiac events in left-sided breast cancers.
In this article, we focus on the potential explanations for trialists' decision to initiate further trials of TXA, yet there is also a question regarding why patients continue to agree to participate in apparently 'redundant' trials in which there is a chance they will forego receiving an effective treatment.
Information regarding the quality of the three unpublished studies was obtained from trial protocols and personal communication with the trialists.
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CEO of Professional Science Editing for Scientists @ prosciediting.com