عنوان

Analysis of safety data of drug trials :

شابک

3030058042

شابک

3030058050

شابک

9783030058043

شابک

9783030058050

شابک اشتباه

3030058034

شابک اشتباه

9783030058036

عنوان اصلي

Analysis of safety data of drug trials :

نام عام مواد

[Book]

ساير اطلاعات عنواني

an update /

نام نخستين پديدآور

Ton J. Cleophas, Aeilko H. Zwinderman.

محل نشرو پخش و غیره

Cham, Switzerland :

نام ناشر، پخش کننده و غيره

Springer,

تاریخ نشرو بخش و غیره

[2019]

نام خاص و کميت اثر

1 online resource

متن يادداشت

Includes bibliographical references and index.

متن يادداشت

Preface -- General Introduction -- Significant and Insignificant Adverse Effect -- Incidence Ratios and Reporting Ratios of Adverse Effects -- Safety Analysis and the Alternative Hypothesis -- Forest Plots of Adverse Effects -- Graphics of Adverse Effects -- Repeated Measures Methods for Testing Adverse Effects -- Benefit Risk Ratios -- Equivalence, Non-inferiority and Superiority Testing of Adverse Effects -- Part II The Analysis of Dependent Adverse Effects -- Independent and Dependent Adverse Effects. Categorical Predictors Assessed as Dependent Adverse Effects. Adverse Effect of the Dependent Type in Crossover Trial -- Confoundings and Interactions Assessed as Dependent Adverse Effects -- Subgroup Characteristics Assessed as Dependent Adverse Effects -- Random Effects Assessed as Dependent Adverse Effects -- Outliers Assessed as Dependent Adverse Effects -- Index.

بدون عنوان

0

متن يادداشت

The authors, as professors in statistics at various universities in Europe, are worrried about the poor quality of safety data analysis of clinical trials, despite its importance in drug development and pharmacovigilance. Clinical trials, not adequately addressing safety, are unethical. An effective approach for the purpose is to present summaries of prevalences. In order to estimate the probability, that the differences between treatment and control group did not occur merely by chance, a statistical test can be performed. This pretty crude method has recently be supplemented with better sensitive methodologies, based on machine learning clusters and networks, and multivariate analyses. Another important novelty with safety data analysis is the new insights into hypothesis testing, favoring the alternative hypotheses instead of the null hypotheses. Finally the issue of dependency is addressed. Adverse effects may be either dependent or independent of the main outcome. Dependent adverse effect are dependent not only on the treatment modalities, but also on the outcome of the trials. Random heterogeneities, outliers, confounders, interaction factors are common in clinical trials, and all of them can be considered kinds of adverse effects of the dependent type. Random regressions and analyses of variance, high dimensional clusterings, partial correlations, structural equations models, and other Bayesian methods are helpful for their analysis. The current edition was particularly written for medical and health professionals and students. It provides examples of modern analytic methods so far largely unused. All of the 16 chapters have two core characteristics, first they are for current usage, second they try and tell what readers need to know in order to understand the methods. Step by step analyses are given and self-assessment examples are supplied. Each chapter can be studied as a stand-alone.

منبع سفارش / آدرس اشتراک

Springer

عنوان

Analysis of safety data of drug trials.

شماره استاندارد بين المللي کتاب و موسيقي

9783030058036

موضوع مستند نشده

Drugs-- Side effects.

موضوع مستند نشده

Drugs-- Testing.

موضوع مستند نشده

Drug Evaluation-- methods.

موضوع مستند نشده

Safety.

موضوع مستند نشده

Drugs-- Side effects.

موضوع مستند نشده

Drugs-- Testing.

موضوع مستند نشده

MBGR

موضوع مستند نشده

MBGR

موضوع مستند نشده

MED000000

شماره

ويراست

شماره رده

نشانه اثر

شماره رده

مستند نام اشخاص تاييد نشده

Cleophas, Ton J. M.

مستند نام اشخاص تاييد نشده

Zwinderman, Aeilko H.

تاريخ عمليات

20200823081846.0

قواعد فهرست نويسي ( بخش توصيفي )

pn

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y