Data Monitoring Committees (DMCs): Past, Present, and Future - Image 1

£65.02

Springer Data Monitoring Committees (DMCs): Past, Present, and Future

Name: Data Monitoring Committees (DMCs): Past, Present, and Future
Brand: Springer
Price: 64.26 GBP
Availability: InStock

Allied Health Professions

Price History & Forecast

Last 35 days • 35 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 35 days • 2 price levels

Days at Price

Current Price

Price Analysis

Most common price: £65 (18 days, 51.4%)

Price range: £64 - £65

Price levels: 2 different prices over 35 days

Description

This book provides an overview of Data Monitoring Committees(DMC) - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotechnology and pharmaceutical company and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity. This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to expertly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the impact of DMC activity on safeguarding the trial is so important. This book provides the following: Provides thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation; Includes practical and hands-on information on DMC implementation; Discusses a wide range of clinical trial – by phase and therapeutic area.

Product Specifications

Brand: Springer
Format: hardcover
ASIN: 3031287592
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions
Domain: Amazon UK
Release Date: 09 June 2023
Listed Since: 17 February 2023

Barcode

No barcode data available

Springer Data Monitoring Committees (DMCs): Past, Present, and Future

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Data Monitoring Committees (DMCs): Past, Present, and Future

Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice)

Data and Safety Monitoring Committees in Clinical Trials (Chapman & Hall/CRC Biostatistics Series)

Practical Guide to Clinical Data Management

Multiregional Clinical Trials for Simultaneous Global New Drug Development (Chapman & Hall/CRC Biostatistics Series)

Demos Medical Oncology Clinical Trials Design and Analysis Book

Management of Data in Clinical Trials (Wiley Series in Probability and Statistics)

A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials: Handbooks of Modern Statistical Methods (Chapman & Hall/CRC Handbooks of Modern Statistical Methods)

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials: Handbooks of Modern Statistical Methods (Chapman & Hall/CRC Handbooks of Modern Statistical Methods)

Oncology Clinical Trials: Successful Design, Conduct, and Analysis

Phase II Clinical Development of New Drugs (ICSA Book Series in Statistics)

Multiregional Clinical Trials for Simultaneous Global New Drug Development (Chapman & Hall/CRC Biostatistics Series)

Principles of Clinical Cancer Research

Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods (Chapman & Hall/CRC Biostatistics Series)

Springer Statistical Monitoring of Clinical Trials Textbook

Textbook of Clinical Trials in Oncology: A Statistical Perspective

Case Studies in Innovative Clinical Trials (Chapman & Hall/CRC Biostatistics Series)

Clinical Trial Biostatistics and Biopharmaceutical Applications

Monte-Carlo Simulation-Based Statistical Modeling (ICSA Book Series in Statistics)

DAMA-DMBOK: Data Management Body of Knowledge: 2nd Edition

Clinical Research Law and Ethics: Human Research and a Complete Practical Guide to Regulatory Compliance

Contract Research and Development Organizations-Their History, Selection, and Utilization

Quantitative Decisions in Drug Development (Springer Series in Pharmaceutical Statistics)