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(data safety monitoring board)
994 results
  • Understanding the functions and operations of data monitoring committees: Survey and focus group findings. [Journal Article]
  • CTClin Trials 2016 Nov 01; :1740774516679665
  • Calis KA, Archdeacon P, … DeMets DL
  • CONCLUSIONS: Findings from the survey and focus groups provide a better understanding of contemporary data monitoring committee operations and insights regarding challenges and best practices. Overall, it was clear that increased training will be needed to prepare the next generation of qualified data monitoring committee members to meet the growing demand. These findings can be used by Clinical Trials Transformation Initiative and others to develop recommendations and tools to improve data monitoring committee operations and the overall quality of trial oversight.
  • An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol. [Journal Article]
  • JRJMIR Res Protoc 2016 Nov 23; 5(4):e226
  • Joviliano EE, Yoshida WB, … Almeida MJ
  • CONCLUSIONS: The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil.
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