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Charting the content of data monitoring committee charters for clinical trials [PDF]
Clinical TrialsBackground: Data monitoring committees play a critical role in ensuring the ethical conduct of clinical trials. Data monitoring committee charters set out the role and processes for data monitoring committees in monitoring clinical trials; however, little is known about the information charters contain.
Lisa Eckstein +4 more
europepmc +4 more sources
Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials [PDF]
Journal of Biopharmaceutical Statistics, 2014 Data monitoring committees (DMCs) have important roles in safeguarding patient interests and enhancing trial integrity and credibility. To effectively fulfill their responsibilities, DMCs should be independent of study sponsors, study investigators, and caregivers managing study participants.
Thomas R. Fleming +3 more
openalex +4 more sources
The Necessity of Independent Data Monitoring Committee in Domestic Clinical Trials [PDF]
Korean Journal of Applied Statistics, 2009 In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if
Seung‐Ho Kang
openalex +3 more sources
Approach to the state of the art of data monitoring committees in clinical trials
Revista Cubana de Medicina Militar, 2021 Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the ...
Sonia Pérez Rodríguez +4 more
doaj +1 more source
Safety and data monitoring committees for clinical trials [PDF]
Clinical Cardiology, 1995 C. Richard Conti
openalex +3 more sources
Clinical Trial Independent Data Monitoring Committee Member List [PDF]
, 2020 National Cancer Institute
openalex +2 more sources
Data and Safety Monitoring Committees in Clinical Trials [PDF]
Journal of the Royal Statistical Society Series A: Statistics in Society, 2010 Andrea M. Rehman
openalex +2 more sources
Clinical Trial Independent Data Monitoring Committee Correspondence [PDF]
, 2020 National Cancer Institute
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Clinical Trial Independent Data Monitoring Committee Charter [PDF]
, 2020 National Cancer Institute
openalex +2 more sources