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The Complexity of Conducting a Multicenter Clinical Trial: Taking It to the Next Level Stipulated by the Federal Agencies.

ABSTRACT: Randomized controlled trials are becoming increasingly difficult to organize and conduct efficiently. This, in turn, hinders the ability to derive the highest level of evidence. Often, investigators forget or remain unaware of essential practices that will help them fulfill their study goals. This article emphasizes the common issues that a study team experiences during the planning and conducting of randomized controlled trials. The authors sought to share remedies to overcome these issues with the experience garnered in conducting several multicenter clinical trials and observational studies. In addition, the authors list resources from sponsors such as the National Institutes of Health and the U.S. Food and Drug Administration that study teams can apply to undertake studies effectively.

SUBMITTER: Chung KC

PROVIDER: S-EPMC6905126 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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The Complexity of Conducting a Multicenter Clinical Trial: Taking It to the Next Level Stipulated by the Federal Agencies.

Chung Kevin C KC Malay Sunitha S Shauver Melissa J MJ

Plastic and reconstructive surgery 20191201 6

Randomized controlled trials are becoming increasingly difficult to organize and conduct efficiently. This, in turn, hinders the ability to derive the highest level of evidence. Often, investigators forget or remain unaware of essential practices that will help them fulfill their study goals. This article emphasizes the common issues that a study team experiences during the planning and conducting of randomized controlled trials. The authors sought to share remedies to overcome these issues with ...[more]

PMID: 31764675

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Project description:Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime. In this context, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care, although they are associated with relevant limitations. Accordingly, culture-independent molecular diagnostic procedures might be of help for the identification of the causative pathogen in infected patients. The concept of an unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) has recently been identified to be a promising diagnostic platform for critically ill patients suffering from bloodstream infections. Although this new approach might be more sensitive and specific than culture-based state-of-the-art technologies, additional clinical trials are needed to exactly define the performance as well as clinical value of a NGS-based approach.Next GeneSiS is a prospective, observational, noninterventional, multicenter study to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in patients with suspected or proven sepsis [according to recent sepsis definitions (sepsis-3)] by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard (culture-based) microbiological diagnostics. The clinical value of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients' management based on NGS results. Further subgroup analyses will focus on the clinical value especially for patients suffering from a failure of empiric treatment within the first 3 days after onset [as assessed by death of the patient or lack of improvement of the patient's clinical condition (in terms of an inadequate decrease of SOFA-score) or persistent high procalcitonin levels].This prospective, observational, noninterventional, multicenter study for the first time investigates the performance as well as the clinical value of a NGS-based approach for the detection of bacteremia in patients with sepsis and may therefore be a pivotal step toward the clinical use of NGS in this indication.DRKS-ID: DRKS00011911 (registered October 9, 2017) https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011911; ClinicalTrials.gov Identifier: NCT03356249 (registered November 29, 2017) https://clinicaltrials.gov/ct2/show/NCT03356249.

Dataset Information

The Complexity of Conducting a Multicenter Clinical Trial: Taking It to the Next Level Stipulated by the Federal Agencies.

Publications

The Complexity of Conducting a Multicenter Clinical Trial: Taking It to the Next Level Stipulated by the Federal Agencies.

Similar Datasets

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