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clinical trials
Items for "clinical trials"
Creative and Innovative Statistics in Clinical Research and Development
Objectives: The aim of this paper is to show that even in a highly regulated area such as clinical research and development in pharmaceutical industry, there are needs and ample opportunities for statisticians and other medical informatics professionals to further creatively develop and implement methods in order to support the collection, analysis and interpretation of clinical data. Methods: The recently published Critical Path initiative of the US Food and Drug Administration discusses the decline in new drug submissions in the last decade and illustrates potential causes in the present clinical development process...
Keywords: Drug evaluation, drug approval, clinical trials, biometry, statistical m
01/2005 | Methods of Information in Medicine, SchattauerAdaptFlow: Protocol-based Medical Treatment Using Adaptive Workflows
OBJECTIVES: In many medical domains investigator-initiated clinical trials are used to introduce new treatments and hence act as implementations of guideline-based therapies...
Keywords: clinical trials, clinical protocols, Guidelines, eventoriented exception handling, adaptive workflow management
01/2005 | Methods of Information in Medicine, SchattauerDesigning New Methodologies for Integrating Biomedical Information in Clinical Trials
Objectives: To propose a modification to current methodologies for clinical trials, improving data collection and cost-efficiency...
Keywords: Database integration, clinical trials, Ontologies, Biomedical Informatics, Genomic medicine
01/2006 | Methods of Information in Medicine, SchattauerAntithrombotic effects of ximelagatran plus acetylsalicylic acid (ASA) and clopidogrel plus ASA in a human ex vivo arterial thrombosis model
It was the objective of this study to compare the antithrombotic effects and bleeding profiles of the oral direct thrombin inhibitor ximelagatran, an anticoagulant, and the antiplatelet agent clopidogrel on top of steady-state acetylsalicylic acid (ASA) in a human arterial thrombosis model...
Keywords: clinical trials, oral anticoagulants, coagulation inhibitors,thrombin
03/2006 | Thrombosis and Haemostasis, SchattauerPerformance evaluation of the new CoaguChek XS system compared with the established CoaguChek system by patients experienced in INR-self management
The aim of the study was to analyze the concordance of INR values obtained by educated lay users with those obtained by professionals and to determine the imprecision of the new system...
Keywords: Patients education, clinical trials, oral anticoagulants, home monitoring, INR-self management
00/0000 | Thrombosis and Haemostasis, SchattauerComparison of Time–to–Event Data for Clinical Trials
Ratios of random variables arise frequently in medical–pharmaceutical applications. A selected review of this literature is provided, followed by a new method to compare time–to–event data from clinical trials...
Keywords: clinical trials, Pareto and gamma distributions, method of moments
04/2007 | Monte Carlo Methods and Applications, Walter de GruyterLaboratory testing in clinical trials under consideration of the ICH-GCP guideline1
Clinical trials are a prerequisite for the launch and registration of new drugs. During recent years the regulations have become more strict worldwide including Germany...
Keywords: clinical trials, German law governing the manufacture and prescription of drug, German drugs act, ICH-GCP guideline, laboratory testing, legal rules
09/2008 | LaboratoriumsMedizin, Walter de GruyterLaboranalytik im Rahmen klinischer Studien unter Berücksichtigung der ICH-GCP-Leitlinie / Laboratory testing in clinical trials under consideration of the ICH-GCP guideline
Zusammenfassung Klinische Studien sind für die Einführung und Zulassung neuer Arzneimittel unverzichtbar...
Keywords: Arzneimittelgesetz, ICH-GCP-Leitlinie, Klinische Studien, Laboranalytik, rechtliche Normen, clinical trials, German law governing the manufacture and prescription of drugs, International Conference on Harmonization-Good Clinical Practice guideline, laboratory testing, legal rules
09/2008 | LaboratoriumsMedizin, Walter de Gruyter