Academic Journal
Optimising the analysis strategy for the CANVAS Program - a pre-specified plan for the integrated analyses of the CANVAS and CANVAS-R trials
| العنوان: | Optimising the analysis strategy for the CANVAS Program - a pre-specified plan for the integrated analyses of the CANVAS and CANVAS-R trials |
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| المؤلفون: | Neal, B, Perkovic, V, Mahaffey, KW, Fulcher, G, Erondu, N, Desai, M, Shaw, W, Law, G, Walton, MK, Rosenthal, N, Zeeuw, D, Matthews, DR, CANVAS program collaborative group |
| المصدر: | 935 ; 926 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2017 |
| المجموعة: | Imperial College London: Spiral |
| مصطلحات موضوعية: | Science & Technology, Life Sciences & Biomedicine, Endocrinology & Metabolism, cardiovascular disease, SGLT2 inhibitor, type 2 diabetes, CANAGLIFLOZIN CARDIOVASCULAR ASSESSMENT, BASE-LINE CHARACTERISTICS, PLACEBO-CONTROLLED TRIAL, SAFETY, CONJUNCTION, RATIONALE, EFFICACY, EVENTS, DESIGN, CANVAS Program collaborative group, 1103 Clinical Sciences |
| الوصف: | Two large cardiovascular outcome trials of canagliflozin, the CANVAS Program, will complete in early 2017: the CANagliflozin cardioVascular Assessment Study (CANVAS) and the CANagliflozin cardioVascular Assessment Study - Renal (CANVAS-R). Accruing data for the sodium-glucose co-transporter 2 inhibitor (SGLT2i) class has identified questions and opportunities that were not apparent when the trials were designed. Accordingly, a series of modifications have been made to the planned analyses. These updates will ensure that the data from the CANVAS Program will maximise advances in scientific knowledge and patient care. The specification of the analysis strategy prior to knowledge of the trial results, their design by the independent scientific trial Steering Committee, the detailed a priori definition of the analysis plans and the external review provided by the US Food and Drug Administration, all provide for a maximally efficient and robust utilisation of the data. The CANVAS Program should significantly advance our understanding of the effects of canagliflozin, and the broader SGLT2i class, on a range of important efficacy and safety outcomes. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1463-1326 |
| Relation: | Diabetes Obesity & Metabolism; http://hdl.handle.net/10044/1/44986; https://dx.doi.org/10.1111/dom.12924 |
| DOI: | 10.1111/dom.12924 |
| الاتاحة: | http://hdl.handle.net/10044/1/44986 https://doi.org/10.1111/dom.12924 |
| Rights: | © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
| رقم الانضمام: | edsbas.4D196353 |
| قاعدة البيانات: | BASE |
| تدمد: | 14631326 |
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| DOI: | 10.1111/dom.12924 |