Preface -- Contents -- Part I General Introduction to Composite Endpoints -- 1 Definition and Rationale -- 2 Challenges of Composite Endpoints -- 3 Guideline View -- Recommendations and Requirements -- 4 Clinical Trial Examples -- Part II Confirmatory Test Problem for a Single (Composite) Endpoint -- 5 The Single-Stage Design -- 6 Group-Sequential and Adaptive Designs -- 7 Related Software Code -- Part III Confirmatory Multiple Test Problem -- 8 Correlation Between Test Statistics -- 9 The Single-Stage Design -- 10 Group-Sequential and Adaptive Designs -- 11 Related Software Code -- Part IV Confirmatory Test Problem for a Weighted Composite Endpoint -- 12 Weighted Binary Composite Endpoint -- Weighted Time-to-Event Composite Endpoint -- 14 OtherWeighted Effect Measures -- 15 Related Software Code -- Part V Descriptive and Confirmatory Evaluation of the Components -- 16 Descriptive Analysis of the Components -- 17 Supplementary Confirmatory Analyses of the Components -- 18 Related Software Code -- Part VI Illustrating Clinical Trial Examples -- 19 Clinical Trial Examples with Binary (Composite) Endpoints -- 20 Clinical Trial Examples with (Composite) Time-to-Event Endpoints.
بدون عنوان
0
یادداشتهای مربوط به خلاصه یا چکیده
متن يادداشت
This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.
یادداشتهای مربوط به سفارشات
منبع سفارش / آدرس اشتراک
Springer Nature
شماره انبار
com.springer.onix.9783319737706
ویراست دیگر از اثر در قالب دیگر رسانه
شماره استاندارد بين المللي کتاب و موسيقي
9783319737690
موضوع (اسم عام یاعبارت اسمی عام)
موضوع مستند نشده
Clinical trials-- Statistical methods.
موضوع مستند نشده
Clinical trials-- Statistical methods.
موضوع مستند نشده
HEALTH & FITNESS-- Holism.
موضوع مستند نشده
HEALTH & FITNESS-- Reference.
موضوع مستند نشده
Life sciences: general issues.
موضوع مستند نشده
MEDICAL-- Alternative Medicine.
موضوع مستند نشده
MEDICAL-- Atlases.
موضوع مستند نشده
MEDICAL-- Essays.
موضوع مستند نشده
MEDICAL-- Family & General Practice.
موضوع مستند نشده
MEDICAL-- Holistic Medicine.
موضوع مستند نشده
MEDICAL-- Osteopathy.
موضوع مستند نشده
Pharmaceutical technology.
موضوع مستند نشده
Probability & statistics.
مقوله موضوعی
موضوع مستند نشده
HEA-- 012000
موضوع مستند نشده
HEA-- 020000
موضوع مستند نشده
MED-- 004000
موضوع مستند نشده
MED-- 029000
موضوع مستند نشده
MED-- 040000
موضوع مستند نشده
MED-- 092000
موضوع مستند نشده
MED-- 101000
موضوع مستند نشده
MED-- 109000
رده بندی ديویی
شماره
610
.
72/7
ويراست
23
رده بندی کنگره
شماره رده
R853
.
C55
نام شخص به منزله سر شناسه - (مسئولیت معنوی درجه اول )