Results 291 to 300 of about 1,987,834 (344)

Data Monitoring Committees and Interim Monitoring Guidelines

Controlled Clinical Trials, 1999
Most large randomized clinical trials have a data monitoring committee that periodically examines efficacy and safety results. A typical data monitoring committee meets every 6 months, but the interim monitoring guidelines for many trials specify formal analyses that are years apart.
B, Freidlin, E L, Korn, S L, George
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The independent statistician for data monitoring committees

Statistics in Medicine, 2004
AbstractClinical trials are an essential part of the clinical research process. Recently, independent Data Monitoring Committees (DMCs) have been widely implemented to provide scientific and ethical oversight of pivotal clinical trials having irreversible outcomes such as death, stroke, disease recurrence or a serious adverse event.
David L, DeMets, Thomas R, Fleming
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Bringing data monitoring committee charters into the sunlight

Clinical Trials, 2023
Clinical trials investigating novel or high risk interventions, or studying vulnerable participants, often use a data monitoring committee to oversee the progress of the trial. The data monitoring committee serves both an ethical and a scientific function, by protecting the interests of trial participants while ensuring the integrity of the trial ...
David L DeMets, Deborah A Zarin, Frank Rockhold, Susan S Ellenberg, Thomas Fleming, Janet Wittes   +5 more
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Responsibilities of Data Monitoring Committees: Consensus Recommendations

Therapeutic Innovation & Regulatory Science, 2016
A data monitoring committee (DMC) has special responsibilities for protecting the safety of clinical trial participants. Few guidance documents are available that address the operations and mechanics of establishing, serving on, or reporting to a DMC. This article provides a practical guide to sponsors, institutions, and individuals responsible for, or
Barbara E, Bierer, Rebecca, Li, Jonathan, Seltzer, Lynn A, Sleeper, Elizabeth, Frank, Charles, Knirsch, Carmen E, Aldinger, Robert J, Levine, Joe, Massaro, Amish, Shah, Mark, Barnes, Steven, Snapinn, Janet, Wittes   +12 more
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Data Monitoring and Safety Committees and Their Operations

Obstetrical & Gynecological Survey, 2003
The scientific burden of proof for new therapies and technologies in obstetrics and gynecology has risen steadily over the past 15 to 20 years, and the randomized clinical trial has become integral to this higher standard. Data monitoring and safety committees are now critical components of clinical trials, yet their history, rationale, methods of ...
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Futility approaches to interim monitoring by data monitoring committees

Clinical Trials, 2006
Clinical trials involving participants with high risk of serious events or being exposed to a new intervention with potential serious risk are typically monitored during the course of the trial. Often, this monitoring activity is conducted by an independent group of experts, often referred to as a Data Monitoring Committee (DMC).
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Regulatory Reply to the ATMOSPHERE Data Monitoring Committee

New England Journal of Medicine, 2016
To the Editor: We agree with Swedberg et al.,1 whose Sounding Board article is now published in the Journal, regarding the role and responsibilities of the data monitoring committee. We also agree that the data monitoring committee should be allowed to act independently during the progress of a trial.
Tomas, Salmonson, Heidi, Janssen, Thomas, Sudhop, Elke, Stahl   +3 more
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The Data Monitoring Committee: How It Operates and Why

IRB: Ethics and Human Research, 1981
Conducting a clinical trial usually requires reviewing various aspects of the trial, including the appropriateness of the protocol, the informed consent process, and subject compliance with the protocol; data accumulated during the course of the study must also be reviewed periodically. This latter activity, often referred to as data monitoring, is one
Lawrence, Friedman, David, DeMets
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Data Monitoring Committee Reports: Telling the Data’s Story

Therapeutic Innovation & Regulatory Science
A Data Monitoring Committee (DMC) plays a pivotal role in monitoring participant safety and efficacy and overseeing the integrity of clinical trials. DMCs accomplish this mission by periodically reviewing accumulating data to assess benefits and harms of interventions in ongoing studies and making subsequent recommendations regarding future clinical ...
Lijuan, Zeng, Toshimitsu, Hamasaki, Scott R, Evans   +2 more
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Terms of reference for Data and Safety Monitoring Committees

American Heart Journal, 2001
The Data and Safety Monitoring Committee (DSMC) constitutes one of the most complex elements of a clinical trial. For this reason, it is critical that all participants in and contributors to a trial understand the functions and responsibilities of the DSMC.
M, Packer, J, Wittes, D, Stump
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