271 research outputs found
sj-docx-1-ctj-10.1177_17407745211051279 – Supplemental material for Data monitoring committee interim reports: We must get there soon!
No full textSupplemental material, sj-docx-1-ctj-10.1177_17407745211051279 for Data monitoring committee interim reports: We must get there soon! by David L DeMets and Janet Wittes in Clinical Trials</p
Computations for Group Sequential Boundaries Using the Lan-DeMets Spending Function Method
No full textToujours loyal : a middle Dutch chronicle of Flanders by Jan van Dixmude in sixteenth-century Ghent
No full textThe political and social milieus in which manuscripts circulated offer new insights into the writing aims of the material author(s) or scribe(s) and the interpretation strategies of subsequent owners. In this light, this contribution reconsiders the writing context of the so-called Chronicle of pseudo-Jan van Dixmude. By confronting the material and textual information provided by the original manuscript (Ghent, University Library, G. 6181), the manuscript can be related to a politically ambitious family in sixteenth-century Ghent. The writing of medieval Flemish historiography in fifteenth- and sixteenth-century Flanders seems to be closely related to the practice of politics, more particularly in moments of crisis such as revolts. Jan van Dixmude’s manuscript version of the Middle Dutch Chronicle of Flanders or Excellente Cronike van Vlaenderen provides new insights into the social and political identities of late medieval patricians aspiring noble ambitions
The independent statistician model: How well is it working?
No full text With the initiation in the late 1960s of the data and safety monitoring board or equivalently the data monitoring committee in randomized clinical trials came the need for interim statistical reports for these committees to review for study conduct and early evidence of harm or overwhelming evidence of benefit, perhaps leading to early trial termination. Initially, the statistical team was part of the data coordinating center for the trial. Later, starting in the early 1990s in many industry-sponsored trials, this statistical unit was separated organizationally from the team that collected and managed the data. This unit, often referred to as the statistical data analysis center, prepares reports for the data monitoring committee, which cover study conduct, data quality and completeness, primary and secondary outcomes, and safety measures by study arm in an unblinded fashion. The role of the statistical data analysis center is critical to any well-functioning data monitoring committee. With the proliferation of data monitoring committees has grown the need for many more well-trained and experienced statistical data analysis centers. In my experience, some such units perform their tasks extremely well but many do not. There is a tremendous need and opportunity to provide training for statistical data analysis centers, and what sponsors and data monitoring committees should expect from statistical data analysis centers. </jats:p
Fraud and misconduct in medical research. Stephen Lock and Frank Wells (eds), London, British Medical Journal, 1993. no. of pages: XI + 202. price: £12.95. ISBN: 0‐7279‐0757‐3
No full textPatient-specific dosing of IIb/IIIa antagonists during acute coronary syndromes: Rationale and design of the PARAGON B study
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