The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups
المؤلفون المشاركون
An, Ming-Wen
Lu, Xin
Sargent, Daniel J.
Mandrekar, Sumithra J.
المصدر
Computational and Mathematical Methods in Medicine
العدد
المجلد 2015، العدد 2015 (31 ديسمبر/كانون الأول 2015)، ص ص. 1-6، 6ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2015-01-15
دولة النشر
مصر
عدد الصفحات
6
التخصصات الرئيسية
الملخص EN
Background.
A phase II design with an option for direct assignment (stop randomization and assign all patients to experimental treatment based on interim analysis, IA) for a predefined subgroup was previously proposed.
Here, we illustrate the modularity of the direct assignment option by applying it to the setting of two predefined subgroups and testing for separate subgroup main effects.
Methods.
We power the 2-subgroup direct assignment option design with 1 IA (DAD-1) to test for separate subgroup main effects, with assessment of power to detect an interaction in a post-hoc test.
Simulations assessed the statistical properties of this design compared to the 2-subgroup balanced randomized design with 1 IA, BRD-1.
Different response rates for treatment/control in subgroup 1 (0.4/0.2) and in subgroup 2 (0.1/0.2, 0.4/0.2) were considered.
Results.
The 2-subgroup DAD-1 preserves power and type I error rate compared to the 2-subgroup BRD-1, while exhibiting reasonable power in a post-hoc test for interaction.
Conclusion.
The direct assignment option is a flexible design component that can be incorporated into broader design frameworks, while maintaining desirable statistical properties, clinical appeal, and logistical simplicity.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
An, Ming-Wen& Lu, Xin& Sargent, Daniel J.& Mandrekar, Sumithra J.. 2015. The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups. Computational and Mathematical Methods in Medicine،Vol. 2015, no. 2015, pp.1-6.
https://search.emarefa.net/detail/BIM-1057834
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
An, Ming-Wen…[et al.]. The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups. Computational and Mathematical Methods in Medicine No. 2015 (2015), pp.1-6.
https://search.emarefa.net/detail/BIM-1057834
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
An, Ming-Wen& Lu, Xin& Sargent, Daniel J.& Mandrekar, Sumithra J.. The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups. Computational and Mathematical Methods in Medicine. 2015. Vol. 2015, no. 2015, pp.1-6.
https://search.emarefa.net/detail/BIM-1057834
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1057834
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر