Statistical monitoring of clinical trials

fundamentals for investigators by Lemuel A. MoyГ©

Publisher: Springer Science+Business Media in New York, London

Written in English
Published: Pages: 254 Downloads: 140
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Subjects:

  • Clinical trials -- Statistical methods.

Edition Notes

Includes bibliographical references and index.

E6) adopted by the ICH, 1 May The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline. The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate aFile Size: KB.   Similar methods could be used to monitor clinical trials, for example, tracking the average number of SAEs per participant in each trial arm over time. At present, paper CRFs are used to report data in many trials, including all trials run within our Clinical Trials Unit (CTU) and 57% of Canadian trials. In our vision for the future, a Cited by: The implementation of statistical methods on safety monitoring is illustrated through clinical trial examples. Practical challenges and considerations are also discussed via . Get this from a library! Statistical monitoring of clinical trials: fundamentals for investigators. [Lemuel A Moyé] -- This book introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases.

Get this from a library! Statistical monitoring of clinical trials: a unified approach. [Michael A Proschan; K K Gordan Lan; Janet Turk Wittes] -- "The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics.   1. Introduction. Statistics are an important aspect of clinical trials. The breadth of statistical issues span the full spectrum of a trial from design and protocol development, data monitoring and conduct during an ongoing trial, data management, data analyses, and reporting of trial Cited by: 2. Get this from a library! Statistical monitoring of clinical trials: fundamentals for investigators. [Lemuel A Moyé] -- Introduces the investigator and statistician to monitoring procedures in clinical research. This book provides the background, correct use, and interpretation of these monitoring procedures at an. This article presents an aid for monitoring clinical trials with failure-time endpoints based on the Bayesian nonparametric analyses of the data. The posterior distribution is a mixture of Dirichlet processes in the presence of censoring if one assumes a Dirichlet process prior Cited by:

Statistical monitoring of clinical trials by Lemuel A. MoyГ© Download PDF EPUB FB2

"The book covers most of the important topics in statistical monitoring of clinical trials, including monitoring boundary, conditional power, inference following a group-sequential trial, and adaptive sample size.[and] is valuable for anyone currently involved with or interested in monitoring clinical by: Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research.

Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research Cited by: 7.

Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research 5/5(1).

From the reviews: "The book covers most of the important topics in statistical monitoring of clinical trials, including monitoring boundary, conditional power, inference following a group-sequential trial, and adaptive sample size.[and] is valuable for anyone currently involved with or interested in Statistical monitoring of clinical trials book clinical trials/5(3).

Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) by Proschan, Michael A.; Lan, K. Gordon; Wittes, Janet Turk published by Springer Hardcover on *FREE* shipping on qualifying offers.4/5(3).

"The book covers most of the important topics in statistical monitoring of clinical trials, including monitoring boundary, conditional power, inference following a group-sequential trial, and adaptive sample size.[and] is valuable for anyone currently involved with or interested in monitoring clinical trials.

Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research Brand: Springer-Verlag New York.

The statistical theory behind conditional power was developed by Lan, along with Simon and Halperin, and was the cornerstone for the conditional error approach to adaptive clinical trials. Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research.

Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research.

This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board.

This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. Statistical Monitoring of Clinical Trials: A Unified Approach Michael A. Proschan, K.

Gordan Lan, Janet Turk Wittes (auth.) The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Statistical monitoring of clinical trials: a unified approach (Book, ) [] Your list has reached the maximum number of items.

Please create a new list with a new name; move some items to a new or existing list; or delete some items. Your request to send this item has been completed. A statistical approach to central monitoring of data quality in clinical trials.

Clin Trials ; 9: Kirkwood AA, Cox T and Hackshaw A. Application of methods for central statistical monitoring in clinical trials. Clin Trials ; Lindblad AS, Manukyan Z, Purohit-Sheth T, et al.

Central site monitoring: results from a. ST Statistical Principles of Clinical Trials Lecture Notes (Modified from Dr. Tsiatis’ Lecture Notes) Daowen Zhang Department of Statistics North Carolina State University c by Anastasios A.

Tsiatis and Daowen Zhang. Request PDF | Statistical Monitoring of Clinical Trials: A Unified Approach | The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with. Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis.

Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) (English Edition) eBook: Michael A.

Proschan, K. 4/5(3). A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related.

The Brownian bridge is not yet used widely in the statistical monitoring of clinical trials. In this paper, we investigate properties of the Brownian bridge and formally derive monitoring rules.

Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) Michael A. Proschan, K.K. Gordon Lan, Janet Turk Wittes The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis.

Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed.

With a focus on finding solutions to these challenges, this book. Centralised statistical monitoring (CSM) is a much cheaper alternative, where data checks are performed by the co-ordinating centre, reducing the need to visit every site.

Although some publications have outlined possible methods, Cited by: 3. The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at.

Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) eBook: Michael A. Proschan, K. Gordon Lan, Janet Turk Wittes: : Kindle Store4/5(3). Living systematic reviews experience multiple testing problems of a kind that are familiar from statistical monitoring of individual clinical trials (Proschan et al., ).

If the study series is. Statistical Monitoring of Clinical Trials: Fundamentals for Investigators: : Lemuel A. Moyé: Books5/5(1). The (technical) statistical content is the main focus of the book and this is what helps it to stand apart from most others on clinical trials (even the more obviously statistically orientated ones).

It takes the reader to quite a technical background that would serve him or her well if moving on to research problems in the various areas.

Statistical Monitoring of Clinical Trials: A Unified Approach Statistics for Biology and Health: : Proschan, Michael A., Lan, K. Gordon, Wittes, Janet /5(2).

Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) eBook: Proschan, Michael A., Lan, K. Gordon, Wittes, Janet Turk /5(2). The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis.

Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is.

Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct. Knepper D(1), Lindblad AS(2), Sharma G(2), Gensler GR(2), Manukyan Z(3), Matthews AG(2), Seifu Y(4).

Author information: (1)1 Drug Development Operations, Allergan, Jersey City, NJ, by: 7. Applied Clinical Trials. Linda B. Sullivan. The Current Status of Risk-Based Monitoring.

Applied Clinical Trials. Buyse M, George SL, Evans S, et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Statistics in Medicine. ;18(24)– FDA.It sometimes refers to site monitoring, i.e., the process of clinical monitors visiting clinical sites to check on protocol adherence and data quality.

The term statistical monitoring will refer to the ongoing process of data review during the trial by the sponsor and data monitoring committee (DMC). Both groups are seeking safety : Jay Herson, Chen Hu.